DETAILED ACTION
This action is in response to the Petition Decision mailed 4/20/2026. PROSECUTION IS HEREBY REOPENED. Currently, claims 1, 7-12, 18-23, 25-27 and 29 are pending in the application. Claims 2-6, 13-17, 24 and 28 are cancelled by Applicant.
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 .
Election/Restrictions
Per the Petition Decision mailed 4/20/2026, Applicant’s arguments with respect to claim 29 have been fully considered and are persuasive. The corresponding Election/Restriction has been withdrawn and claim 29 is examined herein.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 11-12 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Misener (US 2014/0188133) in view of Dowdy (US 5,975,082).
In regards to claim 1, Misener teaches in Figure 25B [0142-0143] and [0154-0155] a sheet (drape 174), the sheet (drape 174) having a length and a width sufficient to establish a procedural field for the medical procedure (a medical drape is understood to have a length and a width sufficient to establish a procedural field for the medical procedure; [0154] teaches “the drape 174 is interposed between the tether connector 632 and the sensor fin 646 to serve as a sterile barrier”) on a side (top side) of the sheet (drape 174) opposite a patient-facing side (bottom side) of the sheet (drape 174); and an integrated conduit (perforations taught in [0155]; [0155] teaches “the slide arms 642A and 642B are then slid toward one another such that the pin contacts 640A and 640B penetrate the drape 174, each defining a perforation therein”) in (0155] teaches “the slide arms 642A and 642B are then slid toward one another such that the pin contacts 640A and 640B penetrate the drape 174, each defining a perforation therein;” Figure 25B teaches the pin contacts 640A and 640B extending through perforations in the drape 174) the sheet (drape 174) for connecting (as shown in Figure 25B) one or more single-use medical devices (tether 134; capable of being used only one time) in the procedural field (as shown in Figure 25B) to another medical device (sensor fin 646) on (as shown in Figure 25B) the patient-facing side (bottom side) of the sheet (drape 174), the integrated conduit (perforations taught in [0155]; [0155] teaches “the slide arms 642A and 642B are then slid toward one another such that the pin contacts 640A and 640B penetrate the drape 174, each defining a perforation therein”) passing through (0155] teaches “the slide arms 642A and 642B are then slid toward one another such that the pin contacts 640A and 640B penetrate the drape 174, each defining a perforation therein;” Figure 25B teaches perforations within the drape 174) the sheet (drape 174) for establishing a multimodal connection consisting of an electrical connection (“electrical pathway” taught in [0143]) and an optical connection (“optical pathway” taught in [0143]) across the procedural barrier ([0143] teaches “Note, however, that the first communication node and second communication node are contemplated as generally referring to various connector interfaces that provide a conductive pathway from the sterile field to the non-sterile field to enable the passage of ECG signals as described above. It is appreciated that the conductive pathway is a communication pathway and includes an electrical pathway, an optical pathway, etc.”) between (as shown in Figure 25B) a single-use medical device (tether 134; capable of being used only one time) of the one or more single-use medical devices (tether 134; capable of being used only one time) to the other medical device (sensor fin 646) on (as shown in Figure 25B) the patient-facing side (bottom side) of the sheet (drape 174) without compromising the procedural field ([0154] teaches “the drape 174 is interposed between the tether connector 632 and the sensor fin 646 to serve as a sterile barrier”).
Misener does not teach the sheet being of one or more nonwoven materials.
However, Dowdy teaches in column 7, lines 53-65 an analogous device with the sheet (“drape”) being of one or more nonwoven materials (column 7, lines 53-65 teaches “the use of nonwoven fabrics for disposable drapes”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the sheet of Misener to be made of one or more nonwoven materials as taught by Dowdy because this element is known to “be relatively soft and have good draping and folding characteristics,” to “be capable of being subjected to a sterilization treatment without being adversely affected” and to provide a disposable drape that “eliminates the laundering, resterilization, and handling costs associated with linen drapes,” as Dowdy teaches in column 7, lines 53-65.
In regards to claim 11, Misener and Dowdy teach the apparatus of claim 1. Misener teaches in [0154] that the procedural barrier is a sterile procedural drape ([0154] teaches “the drape 174 is interposed between the tether connector 632 and the sensor fin 646 to serve as a sterile barrier”).
In regards to claim 12, Misener teaches in Figure 25B, [0134], [0142] and [0154-0155] placing the procedural barrier over a patient, thereby establishing a procedural field for the medical procedure on a side of the procedural barrier opposite a patient- facing side of the procedural barrier ([0134] teaches “a drape 174 is often placed over the patient 70 and employed as a barrier to separate a sterile field of the patient, e.g., areas and components above the drape and proximate to the insertion site 73 (including the catheter 72, the stylet 130, and tether 134 (FIG. 10)) from non-sterile areas outside of the sterile field, e.g., areas and components below the drape, including the patient's chest”); and connecting (via tether connector 632, as shown in Figure 25B) one or more single-use medical devices (tether 134; capable of being used only one time) in the procedural field (as shown in Figure 25B) to another medical device (sensor fin 646) on (as shown in Figure 25B) the patient-facing side (bottom side) of the procedural barrier, the procedural barrier including an integrated conduit (perforations taught in [0155]; [0155] teaches “the slide arms 642A and 642B are then slid toward one another such that the pin contacts 640A and 640B penetrate the drape 174, each defining a perforation therein”) in (0155] teaches “the slide arms 642A and 642B are then slid toward one another such that the pin contacts 640A and 640B penetrate the drape 174, each defining a perforation therein;” Figure 25B teaches the pin contacts 640A and 640B extending through perforations in the drape 174) a sheet (drape 174) for connecting (as shown in Figure 25B) of the one or more single-use medical devices (tether 134; capable of being used only one time) to the other medical device (sensor fin 646) on (as shown in Figure 25B) the patient-facing side (bottom side) of the procedural barrier, the integrated conduit (perforations taught in [0155]; [0155] teaches “the slide arms 642A and 642B are then slid toward one another such that the pin contacts 640A and 640B penetrate the drape 174, each defining a perforation therein”) passing through (0155] teaches “the slide arms 642A and 642B are then slid toward one another such that the pin contacts 640A and 640B penetrate the drape 174, each defining a perforation therein;” Figure 25B teaches perforations within the drape 174) the sheet (drape 174) for establishing a multimodal connection consisting of an electrical connection (“electrical pathway” taught in [0143]) and an optical connection (“optical pathway” taught in [0143]) across the procedural barrier ([0143] teaches “Note, however, that the first communication node and second communication node are contemplated as generally referring to various connector interfaces that provide a conductive pathway from the sterile field to the non-sterile field to enable the passage of ECG signals as described above. It is appreciated that the conductive pathway is a communication pathway and includes an electrical pathway, an optical pathway, etc.”) between (as shown in Figure 25B) a single-use medical device (tether 134; capable of being used only one time) of the one or more single-use medical devices (tether 134; capable of being used only one time) to the other medical device (sensor fin 646) on (as shown in Figure 25B) the patient-facing side (bottom side) of the procedural barrier without compromising the procedural field ([0154] teaches “the drape 174 is interposed between the tether connector 632 and the sensor fin 646 to serve as a sterile barrier”).
Misener does not teach the sheet being of one or more nonwoven materials.
Misener does not teach the sheet being of one or more nonwoven materials.
However, Dowdy teaches in column 7, lines 53-65 an analogous device with the sheet (“drape”) being of one or more nonwoven materials (column 7, lines 53-65 teaches “the use of nonwoven fabrics for disposable drapes”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the sheet of Misener to be made of one or more nonwoven materials as taught by Dowdy because this element is known to “be relatively soft and have good draping and folding characteristics,” to “be capable of being subjected to a sterilization treatment without being adversely affected” and to provide a disposable drape that “eliminates the laundering, resterilization, and handling costs associated with linen drapes,” as Dowdy teaches in column 7, lines 53-65.
In regards to claim 20, Misener and Dowdy teach the method of claim 12. Misener teaches in [0154] that the procedural barrier is a sterile procedural drape ([0154] teaches “the drape 174 is interposed between the tether connector 632 and the sensor fin 646 to serve as a sterile barrier”).
Claim(s) 7, 9 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Misener (US 2014/0188133), in view of Dowdy (US 5,975,082) and further in view of Bui et al. (US 2013/0269713).
In regards to claim 7, Misener and Dowdy teach the apparatus of claim 1. Misener and Dowdy do not teach that the sheet includes one or more plies of the one or more nonwoven materials, each ply of the one or more plies is formed of a nonwoven material of the one or more nonwoven materials, and the nonwoven material is selected from a polypropylene and a wood pulp.
However, Bui et al. teaches in [0072] an analogous device wherein the sheet (surgical drape 90) includes one or more plies ([0072] teaches “surgical drape 90 may be a film-based composite or nonwoven fabric, such as a laminate”) of the one or more nonwoven materials ([0072] teaches “surgical drape 90 may be a film-based composite or nonwoven fabric”), each ply ([0072] teaches “surgical drape 90 may be a film-based composite or nonwoven fabric, such as a laminate”) of the one or more plies ([0072] teaches “surgical drape 90 may be a film-based composite or nonwoven fabric, such as a laminate”) is formed of a nonwoven material ([0072] teaches “surgical drape 90 may be a film-based composite or nonwoven fabric”) of the one or more nonwoven materials ([0072] teaches “surgical drape 90 may be a film-based composite or nonwoven fabric”), and the nonwoven material ([0072] teaches “surgical drape 90 may be a film-based composite or nonwoven fabric”) is selected from a polypropylene ([0072] teaches “surgical drape 90 may be a film-based composite or nonwoven fabric, such as a laminate comprising polypropylene fibers and a polyethylene film”) and a wood pulp.
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the sheet of Misener as modified by Dowdy to include one or more plies of the one or more nonwoven materials, each ply of the one or more plies is formed of a nonwoven material of the one or more nonwoven materials, and the nonwoven material is selected from a polypropylene and a wood pulp as taught by Bui et al. because this material “reduces risk of inadvertent strike-through by sharps (e.g., needles and scalpels),” as Bui et al. teaches in [0072].
In regards to claim 9, Misener, Dowdy and Bui et al. teach the apparatus of claims 1 and 7. Misener, Dowdy and Bui et al. do not teach that the sheet including the one or more plies of the one or more nonwoven materials consists of a single ply of spunlace wood pulp.
However, it would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to provide the one or more plies of the one or more nonwoven materials consisting of a single ply of spunlace wood pulp, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
In regards to claim 18, Misener and Dowdy teach the method of claim 12. Misener and Dowdy do not teach that the sheet includes one or more plies of the one or more nonwoven materials, each ply of the one or more plies formed of a nonwoven material selected from a polypropylene and a wood pulp.
However, Bui et al. teaches in [0072] an analogous method wherein the sheet (surgical drape 90) includes one or more plies ([0072] teaches “surgical drape 90 may be a film-based composite or nonwoven fabric, such as a laminate”) of the one or more nonwoven materials ([0072] teaches “surgical drape 90 may be a film-based composite or nonwoven fabric”), each ply of the one or more plies formed of a nonwoven material selected from a polypropylene ([0072] teaches “surgical drape 90 may be a film-based composite or nonwoven fabric, such as a laminate comprising polypropylene fibers and a polyethylene film”) and a wood pulp.
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the method of Misener as modified by Dowdy to include that the sheet includes one or more plies of the one or more nonwoven materials, each ply of the one or more plies formed of a nonwoven material selected from a polypropylene and a wood pulp as taught by Bui et al. because this material “reduces risk of inadvertent strike-through by sharps (e.g., needles and scalpels),” as Bui et al. teaches in [0072].
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Misener (US 2014/0188133), in view of Dowdy (US 5,975,082), in view of Bui et al. (US 2013/0269713) and further in view of Aguirre (US 2021/0307856).
In regards to claim 8, Misener, Dowdy and Bui et al. teach the apparatus of claims 1 and 7. Misener, Dowdy and Bui et al. do not teach the sheet including the one or more plies of the one or more nonwoven materials consists of a single ply of spunbond polypropylene.
However, Aguirre teaches in [0019] an analogous device wherein the sheet (surgical drape 1) including the one or more plies of the one or more nonwoven materials consists of a single ply of spunbond polypropylene ([0019] teaches “Any suitable surgical drape material (9) or combination of surgical drape materials can be used in the structure of the surgical drape (1) including as illustrative examples: plastic, polyethylene, polypropylene, spunbond polypropylene, meltblown polypropylene, spunlace polypropylene, and combinations thereof, such as laminates including two, three, four, five or more layers of the foregoing materials in various combinations”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the sheet of Misener as modified by Dowdy and Bui et al. to include that the one or more plies of the one or more nonwoven materials consists of a single ply of spunbond polypropylene as taught by Aguirre because this element is known in the art to be a “suitable surgical drape material,” as Aguirre teaches in [0019].
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Misener (US 2014/0188133), in view of Dowdy (US 5,975,082), in view of Bui et al. (US 2013/0269713) and further in view of Turturro et al. (US 2017/0296284).
In regards to claim 10, Misener, Dowdy and Bui et al. teach the apparatus of claims 1 and 7. Misener, Dowdy and Bui et al. do not teach that the sheet including the one or more plies of the one or more nonwoven materials consists of one ply of meltblown polypropylene between two plies of spunbond polypropylene.
However, Turturro et al. teaches in [0074] an analogous device wherein the sheet (folded drape 501) including the one or more plies of the one or more nonwoven materials consists of one ply of meltblown polypropylene between two plies of spunbond polypropylene ([0074] teaches “other materials can be used for the folded drape 501, including, for example, various woven, non-woven, hydroentangled materials, and/or combinations thereof, absorbent Airlaid, spunlace, blends of polyester, polypropylene, polyethylene, urethane, and/or combinations thereof, using various methods, including a spunbond meltblown spundbond (SMS) method, a spunbond meltblown metlblown spundbond method (SMMS), and a spunbond metlblown meltblownspundbond method (SMMMS)”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the sheet including the one or more plies of the one or more nonwoven materials of Misener as modified by Dowdy and Bui et al. to consist of one ply of meltblown polypropylene between two plies of spunbond polypropylene as taught by Turturro et al. because this element is known in the art to be a suitable drape material that is “well known in the art,” as Turturro et al. teaches in [0073-0074].
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Misener (US 2014/0188133), in view of Dowdy (US 5,975,082) and further in view of Aguirre (US 2021/0307856).
In regards to claim 19, Misener and Dowdy teach the method of claims 12 and 18. Misener and Dowdy do not teach that the sheet including the one or more plies of the one or more nonwoven materials consists of a single ply of spunbond polypropylene, a single ply of spunlace wood pulp, or one ply of meltblown polypropylene between two plies of spunbond polypropylene.
However, Aguirre teaches in [0019] an analogous method wherein the sheet (surgical drape 1) including the one or more plies of the one or more nonwoven materials consists of a single ply of spunbond polypropylene ([0019] teaches “Any suitable surgical drape material (9) or combination of surgical drape materials can be used in the structure of the surgical drape (1) including as illustrative examples: plastic, polyethylene, polypropylene, spunbond polypropylene, meltblown polypropylene, spunlace polypropylene, and combinations thereof, such as laminates including two, three, four, five or more layers of the foregoing materials in various combinations”), a single ply of spunlace wood pulp, or one ply of meltblown polypropylene between two plies of spunbond polypropylene.
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the method of Misener as modified by Dowdy to include that the sheet including the one or more plies of the one or more nonwoven materials consists of a single ply of spunbond polypropylene, a single ply of spunlace wood pulp, or one ply of meltblown polypropylene between two plies of spunbond polypropylene as taught by Aguirre because this element is known in the art to be a “suitable surgical drape material,” as Aguirre teaches in [0019].
Claim(s) 21 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Misener (US 2014/0188133), in view of Dowdy (US 5,975,082) and further in view of Adair (US 5,792,045 A).
In regards to claim 21, Misener and Dowdy teach the apparatus of claim 1. Misener and Dowdy do not teach that the integrated conduit is a piece inserted into a fenestration in the sheet.
Claim limitation “molded or extruded” is a product-by-process claim limitation. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
However, Adair teaches in column 5, lines 66-67, column 6, lines 11-12, Figures 2 and 3 and the abstract an analogous device wherein the integrated conduit (disposable sterile coupler 10; the abstract teaches “a passageway is formed inside the coupler that extends from the first end to the second end thereof providing an optical pathway”) is a piece (disposable sterile coupler 10) inserted into a fenestration in (column 5, lines 66-67 teaches “the sterile coupler 10 includes a first end 11 having an annular mounting 15;” column 6, lines 11-12 teaches “an annular mounting 15 is inserted within an opening located at the distal end 26 of the drape 12 such that the opening surrounds neck portion 16”) the sheet (sterile drape 12).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the integrated conduit of Misener as modified by Dowdy to be a piece inserted into a fenestration in the sheet as taught by Adair because this element is known to provide a stronger, more stable integrated conduit structure.
In regards to claim 25, Misener and Dowdy teach the method of claim 12. Misener and Dowdy do not teach that the integrated conduit is a piece inserted into a fenestration in the sheet.
Claim limitation “molded or extruded” is a product-by-process claim limitation. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
However, Adair teaches in column 5, lines 66-67, column 6, lines 11-12, Figures 2 and 3 and the abstract an analogous method wherein the integrated conduit (disposable sterile coupler 10; the abstract teaches “a passageway is formed inside the coupler that extends from the first end to the second end thereof providing an optical pathway”) is a piece (disposable sterile coupler 10) inserted into a fenestration in (column 5, lines 66-67 teaches “the sterile coupler 10 includes a first end 11 having an annular mounting 15;” column 6, lines 11-12 teaches “an annular mounting 15 is inserted within an opening located at the distal end 26 of the drape 12 such that the opening surrounds neck portion 16”) the sheet (sterile drape 12).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the method of Misener as modified by Dowdy to include that the integrated conduit is a piece inserted into a fenestration in the sheet as taught by Adair because this element is known to provide a stronger, more stable integrated conduit structure.
Claim(s) 22, 23, 26, 27 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Misener (US 2014/0188133), in view of Dowdy (US 5,975,082), in view of Adair (US 5,792,045 A) and further in view of Thompson et al. (US 2021/0030504 A1).
In regards to claim 22, Misener, Dowdy and Adair teach the apparatus of claims 1 and 21. Misener, Dowdy and Adair do not teach that the integrated conduit includes an intermediate optical-fiber-containing ferrule disposed therein, the intermediate optical-fiber-containing ferrule complementary to both the single-use medical device of the one or more single-use medical devices and the other medical device on the patient-facing side of the sheet.
However, Thompson et al. teaches in Figures 5A and 8A and [0058] an analogous device wherein the integrated conduit includes an intermediate optical-fiber-containing ferrule (ferrules 865a and 875a; [0058] teaches “ferrules 865a and 875a connect in a straight sleeve-type butt-joint connection for the optical connection;” [0058] teaches “the optical terminal 264, which is a proximal-end portion of an optical fiber such as that of the optical-fiber stylet 252, extends from the plug housing 262 into a ferrule 865a or 865b” and “the optical receiver 772 can include the optical fiber 679 disposed in the ferrule 875a or 875b”) disposed therein, the intermediate optical-fiber-containing ferrule (ferrules 865a and 875a) complementary to both ([0058] teaches “the optical terminal 264, which is a proximal-end portion of an optical fiber such as that of the optical-fiber stylet 252, extends from the plug housing 262 into a ferrule 865a or 865b” and “the optical receiver 772 can include the optical fiber 679 disposed in the ferrule 875a or 875b”) the single-use medical device (stylet extension tube 150, plug 260, plug housing 262, optical terminal 264 and piercing element 266; capable of being used only one time) of the one or more single-use medical devices (stylet extension tube 150, plug 260, plug housing 262, optical terminal 264 and piercing element 266; capable of being used only one time) and the other medical device (receptacle 570) on the patient-facing side (as shown in Figure 5A) of the sheet (drape 201).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the integrated conduit of Misener as modified by Dowdy and Adair to include an intermediate optical-fiber-containing ferrule disposed therein, the intermediate optical-fiber-containing ferrule complementary to both the single-use medical device of the one or more single-use medical devices and the other medical device on the patient-facing side of the sheet as taught by Thompson et al. because this element is known to stabilize and protect the optical fiber of the optical connection.
In regards to claim 23, Misener, Dowdy, Adair and Thompson et al. teach the apparatus of claims 1, 21 and 22. Misener teaches in Figure 25B, [0143] and [0155] that the integrated conduit (perforations taught in [0155]; [0155] teaches “the slide arms 642A and 642B are then slid toward one another such that the pin contacts 640A and 640B penetrate the drape 174, each defining a perforation therein”) includes electrical contacts (pin contacts 640A and 640B; [0155] teaches “the pin contacts 640A and 640B seat within and operably connect with the corresponding contact receptacles 644A and 644B;” [0143] teaches “Note, however, that the first communication node and second communication node are contemplated as generally referring to various connector interfaces that provide a conductive pathway from the sterile field to the non-sterile field to enable the passage of ECG signals as described above. It is appreciated that the conductive pathway is a communication pathway and includes an electrical pathway”) disposed therein (as shown in Figure 25B; [0155] teaches “the slide arms 642A and 642B are then slid toward one another such that the pin contacts 640A and 640B penetrate the drape 174, each defining a perforation therein”), the electrical contacts (pin contacts 640A and 640B) complementary to both (as shown in Figure 25B) the single-use medical device (tether 134; capable of being used only one time) of the one or more single-use medical devices (tether 134; capable of being used only one time) and the other medical device (sensor fin 646) on (as shown in Figure 25B) the patient-facing side (bottom side) of the sheet (drape 174).
In regards to claim 26, Misener, Dowdy and Adair teach the method of claims 12 and 25. Misener, Dowdy and Adair do not teach that the integrated conduit includes an intermediate optical-fiber-containing ferrule disposed therein, the intermediate optical-fiber-containing ferrule complementary to both the single-use medical device of the one or more single-use medical devices and the other medical device on the patient-facing side of the sheet.
However, Thompson et al. teaches in Figures 5A and 8A and [0058] an analogous method wherein the integrated conduit includes an intermediate optical-fiber-containing ferrule (ferrules 865a and 875a; [0058] teaches “ferrules 865a and 875a connect in a straight sleeve-type butt-joint connection for the optical connection;” [0058] teaches “the optical terminal 264, which is a proximal-end portion of an optical fiber such as that of the optical-fiber stylet 252, extends from the plug housing 262 into a ferrule 865a or 865b” and “the optical receiver 772 can include the optical fiber 679 disposed in the ferrule 875a or 875b”) disposed therein, the intermediate optical-fiber-containing ferrule (ferrules 865a and 875a) complementary to both ([0058] teaches “the optical terminal 264, which is a proximal-end portion of an optical fiber such as that of the optical-fiber stylet 252, extends from the plug housing 262 into a ferrule 865a or 865b” and “the optical receiver 772 can include the optical fiber 679 disposed in the ferrule 875a or 875b”) the single-use medical device (stylet extension tube 150, plug 260, plug housing 262, optical terminal 264 and piercing element 266; capable of being used only one time) of the one or more single-use medical devices (stylet extension tube 150, plug 260, plug housing 262, optical terminal 264 and piercing element 266; capable of being used only one time) and the other medical device (receptacle 570) on the patient-facing side (as shown in Figure 5A) of the sheet (drape 201).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the method of Misener as modified by Dowdy and Adair to include that the integrated conduit includes an intermediate optical-fiber-containing ferrule disposed therein, the intermediate optical-fiber-containing ferrule complementary to both the single-use medical device of the one or more single-use medical devices and the other medical device on the patient-facing side of the sheet as taught by Thompson et al. because this element is known to stabilize and protect the optical fiber of the optical connection.
In regards to claim 27, Misener, Dowdy, Adair and Thompson et al. teach the method of claims 12, 25 and 26. Misener teaches in Figure 25B, [0143] and [0155] that the integrated conduit (perforations taught in [0155]; [0155] teaches “the slide arms 642A and 642B are then slid toward one another such that the pin contacts 640A and 640B penetrate the drape 174, each defining a perforation therein”) includes electrical contacts (pin contacts 640A and 640B; [0155] teaches “the pin contacts 640A and 640B seat within and operably connect with the corresponding contact receptacles 644A and 644B;” [0143] teaches “Note, however, that the first communication node and second communication node are contemplated as generally referring to various connector interfaces that provide a conductive pathway from the sterile field to the non-sterile field to enable the passage of ECG signals as described above. It is appreciated that the conductive pathway is a communication pathway and includes an electrical pathway”) disposed therein (as shown in Figure 25B; [0155] teaches “the slide arms 642A and 642B are then slid toward one another such that the pin contacts 640A and 640B penetrate the drape 174, each defining a perforation therein”), the electrical contacts (pin contacts 640A and 640B) complementary to both (as shown in Figure 25B) the single-use medical device (tether 134; capable of being used only one time) of the one or more single-use medical devices (tether 134; capable of being used only one time) and the other medical device (sensor fin 646) on (as shown in Figure 25B) the patient-facing side (bottom side) of the sheet (drape 174).
In regards to claim 29, Misener teaches in Figure 25B [0142-0143] and [0154-0155] a sheet (drape 174), the sheet (drape 174) having a length and a width sufficient to establish a sterile field for the medical procedure (a medical drape is understood to have a length and a width sufficient to establish a sterile field for the medical procedure; [0154] teaches “the drape 174 is interposed between the tether connector 632 and the sensor fin 646 to serve as a sterile barrier”) on a side (top side) of the sheet (drape 174) opposite a patient-facing side (bottom side) of the sheet (drape 174); and an integrated conduit (perforations taught in [0155]; [0155] teaches “the slide arms 642A and 642B are then slid toward one another such that the pin contacts 640A and 640B penetrate the drape 174, each defining a perforation therein”) in (0155] teaches “the slide arms 642A and 642B are then slid toward one another such that the pin contacts 640A and 640B penetrate the drape 174, each defining a perforation therein;” Figure 25B teaches the pin contacts 640A and 640B extending through perforations in the drape 174) the sheet (drape 174) for connecting (as shown in Figure 25B) one or more single-use medical devices (tether 134; capable of being used only one time) in the sterile field (as shown in Figure 25B) to another medical device (sensor fin 646) on (as shown in Figure 25B) the patient-facing side (bottom side) of the sheet (drape 174). Misener teaches in Figure 25B, [0143] and [0155] that the integrated conduit (perforations taught in [0155]; [0155] teaches “the slide arms 642A and 642B are then slid toward one another such that the pin contacts 640A and 640B penetrate the drape 174, each defining a perforation therein”) includes electrical contacts (pin contacts 640A and 640B; [0155] teaches “the pin contacts 640A and 640B seat within and operably connect with the corresponding contact receptacles 644A and 644B;” [0143] teaches “Note, however, that the first communication node and second communication node are contemplated as generally referring to various connector interfaces that provide a conductive pathway from the sterile field to the non-sterile field to enable the passage of ECG signals as described above. It is appreciated that the conductive pathway is a communication pathway and includes an electrical pathway”) disposed in the integrated conduit (as shown in Figure 25B; [0155] teaches “the slide arms 642A and 642B are then slid toward one another such that the pin contacts 640A and 640B penetrate the drape 174, each defining a perforation therein”). Misener teaches in Figure 25B, [0143] and [0155] that the electrical contacts (pin contacts 640A and 640B) are complementary to both (as shown in Figure 25B) the single-use medical device (tether 134; capable of being used only one time) of the one or more single-use medical devices (tether 134; capable of being used only one time) and the other medical device (sensor fin 646) on (as shown in Figure 25B) the patient-facing side (bottom side) of the sheet (drape 174), for establishing a multimodal connection consisting of an electrical connection (“electrical pathway” taught in [0143]) and an optical connection (“optical pathway” taught in [0143]) across the sterile drape ([0143] teaches “Note, however, that the first communication node and second communication node are contemplated as generally referring to various connector interfaces that provide a conductive pathway from the sterile field to the non-sterile field to enable the passage of ECG signals as described above. It is appreciated that the conductive pathway is a communication pathway and includes an electrical pathway, an optical pathway, etc.”) between (as shown in Figure 25B) a single-use medical device (tether 134; capable of being used only one time) of the one or more single-use medical devices (tether 134; capable of being used only one time) to the other medical device (sensor fin 646) on (as shown in Figure 25B) the patient-facing side (bottom side) of the sheet (drape 174) without compromising the sterile field ([0154] teaches “the drape 174 is interposed between the tether connector 632 and the sensor fin 646 to serve as a sterile barrier”).
Misener does not teach the sheet being of one or more nonwoven materials; and wherein: the integrated conduit is a molded or extruded piece inserted into a fenestration of the sheet, the integrated conduit includes an intermediate optical- fiber-containing ferrule disposed in the integrated conduit, the intermediate optical-fiber-containing ferrule is complementary to both a single-use medical device of the one or more single-use medical devices and the other medical device on the patient- facing side of the sheet.
However, Dowdy teaches in column 7, lines 53-65 an analogous device with the sheet (“drape”) being of one or more nonwoven materials (column 7, lines 53-65 teaches “the use of nonwoven fabrics for disposable drapes”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the sheet of Misener to be made of one or more nonwoven materials as taught by Dowdy because this element is known to “be relatively soft and have good draping and folding characteristics,” to “be capable of being subjected to a sterilization treatment without being adversely affected” and to provide a disposable drape that “eliminates the laundering, resterilization, and handling costs associated with linen drapes,” as Dowdy teaches in column 7, lines 53-65.
Misener and Dowdy do not teach wherein: the integrated conduit is a piece inserted into a fenestration of the sheet, the integrated conduit includes an intermediate optical- fiber-containing ferrule disposed in the integrated conduit, the intermediate optical-fiber-containing ferrule is complementary to both a single-use medical device of the one or more single-use medical devices and the other medical device on the patient-facing side of the sheet.
Claim limitation “molded or extruded” is a product-by-process claim limitation. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
However, Adair teaches in column 5, lines 66-67, column 6, lines 11-12, Figures 2 and 3 and the abstract an analogous device wherein the integrated conduit (disposable sterile coupler 10; the abstract teaches “a passageway is formed inside the coupler that extends from the first end to the second end thereof providing an optical pathway”) is a piece (disposable sterile coupler 10) inserted into a fenestration in (column 5, lines 66-67 teaches “the sterile coupler 10 includes a first end 11 having an annular mounting 15;” column 6, lines 11-12 teaches “an annular mounting 15 is inserted within an opening located at the distal end 26 of the drape 12 such that the opening surrounds neck portion 16”) the sheet (sterile drape 12).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the integrated conduit of Misener as modified by Dowdy to be a piece inserted into a fenestration in the sheet as taught by Adair because this element is known to provide a stronger, more stable integrated conduit structure.
Misener, Dowdy and Adair do not teach that the integrated conduit includes an intermediate optical- fiber-containing ferrule disposed in the integrated conduit, the intermediate optical-fiber-containing ferrule is complementary to both a single-use medical device of the one or more single-use medical devices and the other medical device on the patient- facing side of the sheet.
However, Thompson et al. teaches in Figures 5A and 8A and [0058] an analogous method wherein the integrated conduit includes an intermediate optical-fiber-containing ferrule (ferrules 865a and 875a; [0058] teaches “ferrules 865a and 875a connect in a straight sleeve-type butt-joint connection for the optical connection;” [0058] teaches “the optical terminal 264, which is a proximal-end portion of an optical fiber such as that of the optical-fiber stylet 252, extends from the plug housing 262 into a ferrule 865a or 865b” and “the optical receiver 772 can include the optical fiber 679 disposed in the ferrule 875a or 875b”) disposed in the integrated conduit; and the intermediate optical-fiber-containing ferrule (ferrules 865a and 875a) is complementary to both ([0058] teaches “the optical terminal 264, which is a proximal-end portion of an optical fiber such as that of the optical-fiber stylet 252, extends from the plug housing 262 into a ferrule 865a or 865b” and “the optical receiver 772 can include the optical fiber 679 disposed in the ferrule 875a or 875b”) the single-use medical device (stylet extension tube 150, plug 260, plug housing 262, optical terminal 264 and piercing element 266; capable of being used only one time) of the one or more single-use medical devices (stylet extension tube 150, plug 260, plug housing 262, optical terminal 264 and piercing element 266; capable of being used only one time) and the other medical device (receptacle 570) on the patient-facing side (as shown in Figure 5A) of the sheet (drape 201).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the integrated conduit of Misener as modified by Dowdy and Adair to include that the integrated conduit includes an intermediate optical- fiber-containing ferrule disposed in the integrated conduit, and the intermediate optical-fiber-containing ferrule is complementary to both a single-use medical device of the one or more single-use medical devices and the other medical device on the patient- facing side of the sheet as taught by Thompson et al. because this element is known to stabilize and protect the optical fiber of the optical connection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VICTORIA H FISHER whose telephone number is (571)270-7033. The examiner can normally be reached M-TH 6:00AM-4:00PM EST.
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/VICTORIA HICKS FISHER/Primary Examiner, Art Unit 3786 7/28/2026
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