DETAILED ACTION
This is a Non-final Rejection for Application 18/123,884 filed March 20, 2023. This application is a Continuation-in-Part Application of U.S. Patent Application No. 17/063,484 filed October 5, 2020, which claims the benefit of and priority, under 35 U.S.C. § 119(e), to U.S. Provisional Patent Application No. 62/909,895 filed October 03, 2019, and this application claims the benefit of and priority under 35 U.S.C. § 119(e), to U.S. Provisional Patent Application No. 63/321,589 file March 18, 2022. Claims 13-16 and 52-61 are currently pending.
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
Applicant’s election without traverse of Invention II in the reply filed on December 16, 2025 is acknowledged.
Claim Objections
Claim 13 is objected to because of the following informalities.
The recitation “wherein the open celled foam material” in lines 4-5 is objected to as the language being used to refer to the sterile pre-hydrated open celled foam material is not consistent throughout the claim. The sterile pre-hydrated open celled foam material was shortened in line 4 to the foam material, so then referring to the same material as the open celled foam material may lead to confusion. Applicant should be consistent with the claim terminology.
The recitation “wherein foam material comprises about 5 grams…” in lines 5-6 is objected to as the foam material is the same sterile pre-hydrated open celled foam material previously recited and should recite “wherein the foam material comprises about 5 grams…”.
Claim 53 objected to because of the following informalities.
The recitation “the lumen of a trocar” in line 3 is objected to as a trocar is already recited in claim 52 and this is the same trocar previously recited. Therefore, the recitation should recite “the lumen of [[a]] the trocar”.
Claim Rejections - 35 USC § 112(b)
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 13-16 and 58-61 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 13 recites an “absorbed sterile solution” in line 6 however, a saline solution saturates the material. Therefore, it is unclear whether the absorbed sterile solution is the saline solution or another solution. The examiner will interpret the claim as reciting “wherein foam material comprises about 5 grams to about 20 grams of the saline solution”.
Claim 13 further recites “the sterile fluid” in line 8. It is unclear if the sterile fluid is the saline solution or another sterile solution. The examiner will interpret the claim as reciting “removing some of the saline solution by manually wringing the medical device”.
Claim 13 further recites “using the medical device in the operating field” in line 9. an operating field is not previously recited so there is insufficient antecedent basis for this limitation in the claim. This rejection may be overcome with language such as “using the medical device in [[the]] an operating field”.
Claim 58 depends from claim 22, however claim 22 is cancelled. For the purposes of examination, the examiner will interpret claim 58 as depending from claim 57.
Claim 59 recites “the conditioning liquid” in line 6. a conditioning liquid is not previously recited so there is insufficient antecedent basis for this limitation in the claim. This rejection may be overcome with language such as “the solution”.
Claims 14-16 and 60-61 are rejected for depending from and not curing the deficiencies of a rejected claim.
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) 13 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0079590 (Bengtson) in view of US 2001/0022063 (Korteweg et al.) and US 2012/0088958 (Kubisen et al.).
Regarding claim 13, Bengtson discloses a method of performing a medical procedure ([abstract] – “The technical features of the surgical sponge-pad devices make possible unique surgical sponge-pad systems and methods that take advantage of the use, conditioning, and reuse of a single surgical sponge device again and again during a surgical procedure.”), comprising the steps of:
(i) providing a medical device arranged in a closed package ([0043] – “In support of the limited number of surgical sponge-pad devices 18 provided, the surgical sponge-pad system 16 provides the aqueous conditioning liquid 20 (e.g., normal saline) for the surgical sponge-pad devices 18, which is shown packaged in a container 22 prior to use in the operating room (see FIG. 3).” The surgical sponge-pad devices 18 are interpreted as medical devices and are in container 22, which is interpreted as a closed package.),
the medical device comprising a sterile material having a length, width and height ([0039] – “A representative material having these characteristics is medical or surgical, intraoperative type of synthetic chamois. Synthetic chamois material is dust and lint free; that is, it does not flake or shed fibers or the like. Medical Synthetic chamois material can be sterilized, and it possesses a superior liquid absorbing capacity, e.g., a capability of holding up to fifteen times or greater (as noted above), its weight in liquid, and being up to 1500% more absorbent than current sponges used in surgery.” Seeing as the devices 18 are three dimensional, they inherently have a length, width and height.),
wherein the material is saturated with a saline solution ([0039] – “synthetic chamois material can be quickly reconditioned by immersion in a simple aqueous conditioning liquid (e.g., normal saline), where it can be quickly rinsed clean and then residual liquid easily released by manual wringing.”),
wherein the material comprises an ultra-low particulate count ([0008] – “Our device, however, is up to 1500% more absorbent, much more durable, lint and particle free, washable and reusable.” [0009] – “The material is dust and lint free (that is, it does not flake or shed fibers or the like).”),
(ii) removing the medical device from the closed package ([0045] – “The method includes (see FIG. 4) (i) providing the surgical sponge-pad system 16 comprising the limited number of surgical sponge-pad devices 18, the conditioning liquid 20, and the conditioning tray 24. These items can be provided in a sterilized kit, in the manner shown in FIG. 3. These items can be removed from the kit and set up on a prep table outside the operating field by an assistant (see FIG. 4).”);
(iii) removing some of the sterile fluid by manually wringing the medical device ([0047] – “The method further includes (see FIG. 6) (iii) the assistant removing one of the surgical sponge-pad devices 18 (numbered 1) from the conditioning liquid 20 and releasing residual liquid by manual wringing.”);
(iv) using the medical device in the operating field to remove a material or substantially remove a material from a secondary device ([0040] – “The surgical sponge-pad device 18 can be sterilized during a surgical procedure and further be used for cleaning procedure, such as sterilizing the surgical equipment or operating table”); and
(v) discarding the medical device ([0053] – “The method can further include (see FIG. 13) (xiii) at the end of the surgical procedure, discarding the fewer and limited number of surgical sponge-pad devices 18 as medical waste.”).
Bengtson does not disclose that the medical device is pre-hydrated in the closed package; the medical device comprising an open celled foam material; and wherein foam material comprises about 5 grams to about 20 grams of absorbed sterile solution.
However, Korteweg discloses a surgical sponge device with a sponge element 12’ that is packaged in a sealed, moisture vapor-barrier package 20. See Fig. 5. The sponge element 12’ is pre-hydrated in the package 20. [0030] – “The amount of washing liquid that is to be extracted mechanically, following the washing operation, will depend primarily upon the desired condition of the sponge preliminary to packaging. If it is to be packaged and furnished to the consumer in a "wet" state, as depicted for example in FIG. 5, the extraction phase will desirably remove no more than about 90 percent of the amount of liquid that would otherwise be retained; in such instances a degree of wetness that is just sufficient to maintain softness and suppleness will generally be optimal.”
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to pre-hydrate the medical device of Bengtson in the closed package as taught by Korteweg. A skilled artisan would have been motivated to do so because Korteweg teaches that by packaging the sponge in a wet state, the sponge remains soft and supple ([0030]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to surgical sponge devices sealed in closed packaging and configured to be wetted.
As a result, Bengtson in view of Korteweg teaches the medical device is pre-hydrated in the closed package (In view of Korteweg, pre-hydrating the medical device of Bengtson would help retain softness and suppleness of the sponge while in storage.).
Bengtson in view of Korteweg does not teach the medical device comprising an open celled foam material; and wherein foam material comprises about 5 grams to about 20 grams of absorbed sterile solution.
However, Kubisen discloses [abstract] – “A method of packing organs of a subject, the method including accessing an interior cavity of the subject, repositioning the organs to provide a surgical space in the abdominal cavity, and positioning a non-fibrous body against the organs to provide a barrier between the organs and the surgical space.” [0024] – “For example, in one alternative embodiment, a non-fibrous body in accordance with embodiments of the present invention is a foam material, such as a foam wound dressing. In one such embodiment, the foam is an absorbent, open-celled foam, such as a silicone foam or an elastomeric foam.” [0032] – “In one specific arrangement, body 200 is formed from silicone foam or synthetic chamois.” [Claim 35] – “wherein the chamois is a silicone foam/synthetic chamois.” Kubisen teaches that an appropriate chamois material is silicone foam and discloses using the device in a surgical setting.
Additionally, Bengtson discloses [0010] – “Synthetic chamois can be made from, for example, polyvinyl alcohol, polyurethane, polyvinyl acetate, polypropylene, polyester, and polytetrafluoroethylene (PTFE), polyglycolic acid and other like-based materials. Other suitable materials, such as polyester, cellulose materials, micro denier or other cleaning textiles, foam like materials or fabrics may also be used.”
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the medical device of Bengtson to be made of open celled silicone foam as taught by Kubisen. A skilled artisan would have been motivated to do so because Kubisen teaches that silicone foam is absorbent and is beneficial as a non-fibrous material ([0024]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to surgical sponge-like devices.
As a result of the modification, Bengtson in view of Korteweg and Kubisen teaches the medical device comprising an open celled foam material (In view of Korteweg, the material of Bengtson is a silicone foam which is expected to have similar properties to the synthetic chamois of Bengtson.).
Bengtson in view of Korteweg and Kubisen does not directly teach wherein foam material comprises about 5 grams to about 20 grams of absorbed sterile solution.
However, Bengtson does disclose [0011] – “The surgical sponge-pad devices also have an increased absorption rate per area, with absorption rates of at least 0.70 g/in2 and up to and above 5.00 g/in2.” [0027] – “In fact the surgical pad devices may be cut and shaped to unlimited sizes and contours to solve any specific surgical application.” Since the surgical pad device may be any size and the absorption is a function of the area, modifying the device to absorb 5 grams to 20 grams of saline solution is obvious since it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The absorption rate allows for a surgical pad device between 1 in2 with 5.00 g/in2 absorption, which is 5 grams of saline, and 28.5 in2 with 0.70 g/in2 absorption, which is 20 grams of saline.
As a result of the modification, Bengtson in view of Korteweg and Kubisen teaches wherein foam material comprises about 5 grams to about 20 grams of absorbed sterile solution (In view of Bengtson, an amount of saline between about 5 grams and 20 grams is obvious given the unlimited sizes of the device and a range of absorption values.).
Regarding claim 16, Bengtson in view of Korteweg and Kubisen teaches the method of claim 13, wherein the pre-hydrated open celled foam material comprises one of a hydrophilic material and a hydrophobic material (The silicone foam disclosed in Kubisen and applied to Bengtson is hydrophilic as it is absorbent to body fluids.).
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0079590 (Bengtson operation) in view of US 2001/0022063 (Korteweg et al.) and US 2012/0088958 (Kubisen et al.), and further in view of US 4,479,792 (Lazarus et al.).
Regarding claim 14, Bengtson in view of Korteweg and Kubisen teaches the method of claim 13.
Bengtson in view of Korteweg and Kubisen does not teach wherein the secondary device comprises a guide wire.
However, Lazarus discloses a package containing a catheter 12 and a wire guide 14 for use in a peritoneal fluid treatment. See Fig. 1.
Additionally, Bengtson discloses [0008] – “The surgical pad may even be used to clean instruments or placed as a dressing on the patient following the end of the procedure.”
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to include a guide wire in the package of Bengtson as taught by Lazarus. Additionally, it would have been obvious to remove material from the guide wire after its use in a procedure. A skilled artisan would have been motivated to do so because the guide wire is useful in some surgical procedures and removing foreign material after use allows for reuse. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to packages for surgical procedures.
As a result of the combination, Bengtson in view of Korteweg, Kubisen and Lazarus discloses wherein the secondary device comprises a guide wire (In view of Lazarus, a guide wire is included in the package of Bengtson and Bengtson discloses cleaning instruments used in the procedure.).
Regarding claim 15, Bengtson in view of Korteweg and Kubisen teaches the method of claim 13.
Bengtson in view of Korteweg and Kubisen does not teach wherein the secondary device comprises a catheter.
However, Lazarus discloses a package containing a catheter 12 and a wire guide 14 for use in a peritoneal fluid treatment. See Fig. 1.
Additionally, Bengtson discloses [0008] – “The surgical pad may even be used to clean instruments or placed as a dressing on the patient following the end of the procedure.”
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to include a catheter in the package of Bengtson as taught by Lazarus. Additionally, it would have been obvious to remove material from the catheter after its use in a procedure. A skilled artisan would have been motivated to do so because the catheter is useful in some surgical procedures and removing foreign material after use allows for reuse. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to packages for surgical procedures.
As a result of the combination, Bengtson in view of Korteweg, Kubisen and Lazarus discloses wherein the secondary device comprises a catheter (In view of Lazarus, a catheter is included in the package of Bengtson and Bengtson discloses cleaning instruments used in the procedure.).
Claim(s) 52-59 and 61 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0079590 (Bengtson) in view of US 2012/0088958 (Kubisen et al.), US 2005/0246020 (Southworth) and US 2008/0177240 (Kemnitzer II et al.).
Regarding claim 52, Bengtson discloses a method for performing a medical procedure with a continuous use surgical medical device ([abstract] – “The technical features of the surgical sponge-pad devices make possible unique surgical sponge-pad systems and methods that take advantage of the use, conditioning, and reuse of a single surgical sponge device again and again during a surgical procedure.”), comprising:
(i) providing the continuous use surgical medical device comprising a material having an ultra-low number of particles ([0039] – “A representative material having these characteristics is medical or surgical, intraoperative type of synthetic chamois. Synthetic chamois material is dust and lint free; that is, it does not flake or shed fibers or the like. Medical Synthetic chamois material can be sterilized, and it possesses a superior liquid absorbing capacity, e.g., a capability of holding up to fifteen times or greater (as noted above), its weight in liquid, and being up to 1500% more absorbent than current sponges used in surgery.” [0008] – “Our device, however, is up to 1500% more absorbent, much more durable, lint and particle free, washable and reusable.” [0009] – “The material is dust and lint free (that is, it does not flake or shed fibers or the like).”), and
(ii) initially applying a solution to the continuous use surgical medical device to condition for use ([0046] – “The method further includes (see FIG. 5) (ii) the assistant placing the surgical sponge devices 18 (numbered 1 and 2) in the conditioning liquid 20 to initially condition them for use.”);
(iii) removing the continuous use surgical medical device from the solution and releasing residual solution by manual wringing ([0047] – “The method further includes (see FIG. 6) (iii) the assistant removing one of the surgical sponge-pad devices 18 (numbered 1) from the conditioning liquid 20 and releasing residual liquid by manual wringing.”).
Bengtson does not disclose an open-celled foam material; a plurality of radiopaque (RO) ink markers imbedded into a surface of the open-celled foam material configured to be visible under an imaging device at various orientations; having a bacterial endotoxin level below at least 20.0 EU/medical device; (iv) manipulating the continuous use surgical medical device through a lumen of a trocar to clean the lumen of the trocar or condition the trocar; and wherein the conditioned continuous use surgical medical device does not fragment during the manipulating step.
However, Kubisen discloses [abstract] – “A method of packing organs of a subject, the method including accessing an interior cavity of the subject, repositioning the organs to provide a surgical space in the abdominal cavity, and positioning a non-fibrous body against the organs to provide a barrier between the organs and the surgical space.” [0024] – “For example, in one alternative embodiment, a non-fibrous body in accordance with embodiments of the present invention is a foam material, such as a foam wound dressing. In one such embodiment, the foam is an absorbent, open-celled foam, such as a silicone foam or an elastomeric foam.” [0032] – “In one specific arrangement, body 200 is formed from silicone foam or synthetic chamois.” [Claim 35] – “wherein the chamois is a silicone foam/synthetic chamois.” Kubisen teaches that an appropriate chamois material is silicone foam and discloses using the device in a surgical setting.
Additionally, Bengtson discloses [0010] – “Synthetic chamois can be made from, for example, polyvinyl alcohol, polyurethane, polyvinyl acetate, polypropylene, polyester, and polytetrafluoroethylene (PTFE), polyglycolic acid and other like-based materials. Other suitable materials, such as polyester, cellulose materials, micro denier or other cleaning textiles, foam like materials or fabrics may also be used.”
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the medical device of Bengtson to be made of open celled silicone foam as taught by Kubisen. A skilled artisan would have been motivated to do so because Kubisen teaches that silicone foam is absorbent and is beneficial as a non-fibrous material ([0024]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to surgical sponge-like devices.
As a result of the modification, Bengtson in view of Kubisen teaches an open celled foam material (In view of Korteweg, the material of Bengtson is a silicone foam which is expected to have similar properties to the synthetic chamois of Bengtson.).
Kubisen further discloses [0046] – “The non-fibrous body may be collapsed (e.g., rolled, folded or otherwise bunched together) to fit into the cannula of the trocar, small incision or gel port, etc. Sufficient force applied to the non-fibrous absorbent body causes the non-fibrous absorbent body to move through the cannula of the trocar and into the abdominal cavity.” [0016] – “Because the bodies are non-fibrous, little or no fibers remain on the bowels after removal of the bodies from the subject.”
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to include a trocar in the package of Bengtson as taught by Kubisen. A skilled artisan would have been motivated to do so because Kubisen teaches that the trocar allows for the absorbent body to be inserted through a small insertion then expand within the body. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to surgical sponge-like devices.
As a result of the combination, Bengtson in view of Kubisen teaches (iv) manipulating the continuous use surgical medical device through a lumen of a trocar to clean the lumen of the trocar or condition the trocar (In view of Kubisen, the device of Bengtson is manipulated through the lumen of a trocar which results in the device cleaning the trocar as it is pushed in and out of the trocar.); and
wherein the conditioned continuous use surgical medical device does not fragment during the manipulating step (In view of Kubisen, no fibers remain in the surgical site after removal which indicates that the device does not fragment when manipulated through a trocar.).
Bengtson in view of Kubisen does not teach a plurality of radiopaque (RO) ink markers imbedded into a surface of the open-celled foam material configured to be visible under an imaging device at various orientations; having a bacterial endotoxin level below at least 20.0 EU/medical device.
However, Southworth discloses a radiolucent implant with a set of evenly spaced parallel lines of radio-opaque material, such as wires, ink or powder that are embedded within, imprinted upon or adhered to a radiolucent body 104. See [0063].
Additionally, Bengtson discloses [0037] – “Each surgical sponge device 18 can incorporate a radio opaque marker or RFID to aid in the reconciliation of the sponge count before wound closure or to be seen on X-ray if there is a question of one being retained inside a body cavity.”
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to embed a set of evenly spaced parallel lines of radiopaque ink into the sponge device of Bengtson as taught by Southworth. A skilled artisan would have been motivated to do so because Southworth teaches the use of radiopaque ink to mark radiolucent devices within the body and Bengtson discloses that it is desired for a radiopaque material to be used to mark the sponge devices. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to medical devices inserted into the body having radiopaque materials.
As a result of the combination, Bengtson in view of Kubisen and Southworth teaches a plurality of radiopaque (RO) ink markers imbedded into a surface of the open-celled foam material configured to be visible under an imaging device at various orientations (In view of Southworth, a set of evenly spaced parallel lines of radiopaque ink are embedded within the surgical sponge of Bengtson.).
Bengtson in view of Kubisen and Southworth does not teach having a bacterial endotoxin level below at least 20.0 EU/medical device.
However, Kemnitzer discloses a pyrogen-free neurological sponge containing less than 0.45 EU/cm3 of bacterial endotoxins. Kemnitzer discloses a method of producing the surgical sponge comprising the steps of: (a) providing an absorbent material, wherein said absorbent material optionally contains bacterial endotoxins in a concentration of at least 0.45 EU/cm3 of absorbent material; and (b) forming the absorbent material into a sponge, provided that: (1) when the concentration of bacterial endotoxins in the absorbent material is at least 0.45 EU/cm3 of absorbent material, pyrogens are extracted from the absorbent material into a solvent before and/or after the forming step; and (2) when the concentration of bacterial endotoxins in the absorbent material is less than 0.45 EU/cm3 of absorbent material, the forming step is performed under pyrogen-free conditions and/or is followed by a pyrogen extraction step.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for a bacterial endotoxin level to be below 20.0 EU/device by following the method of removing bacterial endotoxins as taught by Kemnitzer. A skilled artisan would have been motivated to do so because Kemnitzer teaches that a low bacterial endotoxin level in each device prevents the buildup of endotoxins as more than one sponge are generally used in a given procedure. A device having 0.45 EU/cm3 can be up to 44.4 cm3 in size before having a bacterial endotoxin level of 20.0 EU and the device of Bengtson can be any size. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to surgical sponges.
As a result of the combination, Bengtson in view of Kubisen, Southworth and Kemnitzer teaches having a bacterial endotoxin level below at least 20.0 EU/medical device (In view of Kemnitzer, the bacterial endotoxin level is below 20.0 EU/device for device 44.4 cm3 in size and smaller.).
Regarding claim 53, Bengtson in view of Kubisen, Southworth and Kemnitzer teaches the method of claim 52, wherein the manipulating the continuous use surgical medical device through a lumen of a trocar step comprises using forceps to manipulate the continuous use surgical medical device through the lumen of a trocar ([0003] – “As shown in FIGS. 1B and 2, it is a common surgical technique to use surgical forceps 12 to manipulate a surgical sponge 10 in an operative field”. In view of Kubisen, the device of Bengtson is manipulated through the lumen of a trocar and manipulation of the sponge is done using forceps.).
Regarding claim 54, Bengtson in view of Kubisen, Southworth and Kemnitzer teaches the method of claim 52, wherein the bacterial endotoxin level is below at least 7.0 EU/medical device (Further limiting the size of the device having 0.45 EU/cm3 to less than 15.5 cm3 is disclosed in Bengtson since the device may be any size.).
Regarding claim 55, Bengtson in view of Kubisen, Southworth and Kemnitzer teaches the method of claim 52, further comprising using the continuous use surgical medical device to clean a camera or other surgical instrument during the procedure ([0040] – “The surgical sponge-pad device 18 can be sterilized during a surgical procedure and further be used for cleaning procedure, such as sterilizing the surgical equipment or operating table”).
Regarding claim 56, Bengtson in view of Kubisen, Southworth and Kemnitzer teaches the method of claim 52, wherein the open-celled foam material comprises one of a hydrophilic foam material and a hydrophobic foam material (The silicone foam disclosed in Kubisen and applied to Bengtson is hydrophilic as it is absorbent to body fluids.).
Regarding claim 57, Bengtson discloses a method for performing a medical procedure with a surgical medical device ([abstract] – “The technical features of the surgical sponge-pad devices make possible unique surgical sponge-pad systems and methods that take advantage of the use, conditioning, and reuse of a single surgical sponge device again and again during a surgical procedure.”), comprising the steps of:
(i) providing the surgical medical device comprising a material having an ultra-low number of particles ([0039] – “A representative material having these characteristics is medical or surgical, intraoperative type of synthetic chamois. Synthetic chamois material is dust and lint free; that is, it does not flake or shed fibers or the like. Medical Synthetic chamois material can be sterilized, and it possesses a superior liquid absorbing capacity, e.g., a capability of holding up to fifteen times or greater (as noted above), its weight in liquid, and being up to 1500% more absorbent than current sponges used in surgery.” [0008] – “Our device, however, is up to 1500% more absorbent, much more durable, lint and particle free, washable and reusable.” [0009] – “The material is dust and lint free (that is, it does not flake or shed fibers or the like).”);
(ii) initially applying a sterile solution to the medical device to condition the medical device for use ([0046] – “The method further includes (see FIG. 5) (ii) the assistant placing the surgical sponge devices 18 (numbered 1 and 2) in the conditioning liquid 20 to initially condition them for use.”);
(iii) removing the medical device from the sterile solution and releasing residual sterile solution by manual wringing ([0047] – “The method further includes (see FIG. 6) (iii) the assistant removing one of the surgical sponge-pad devices 18 (numbered 1) from the conditioning liquid 20 and releasing residual liquid by manual wringing.”);
(iv) manipulating the conditioned medical device in an operating field to absorb blood, body fluids, water and other fluids or materials in an operative site of the operating field ([0047] – “As FIG. 7 shows, the surgeon manipulates the surgical sponge-pad device 18 (numbered 1) in the operating field to absorb blood, body fluids, as well as water and other aqueous liquids in the operative site. ”);
(v) returning the now-used medical device to the sterile solution to clean and rinse it ([0048] – “The method further includes (see FIG. 8) (vi) the surgeon handing the now-used surgical sponge-pad device 18 (numbered 1) to the assistant, who returns it to the conditioning liquid 20 to clean and rinse it.”); and
(vi) repeating steps (iii)-(v) as necessary ([0052] – “ The above-described sequence is repeated as necessary through the remainder of the surgical procedure. While the surgeon reuses a surgical sponge-pad device 18 in the operating field, the assistant reconditions a previously used surgical sponge device 18 for reuse. The surgeon and assistant repeatedly exchange a currently used surgical sponge-pad device 18 for a reconditioned previously used surgical sponge-pad device 18, enabling each surgical sponge-pad device 18 to be reconditioned and reused again and again during the course of the procedure.”).
Bengtson does not disclose an open-celled foam material; a plurality of radiopaque (RO) ink markers imbedded into a surface of the foam material such that the medical device is configured to be visible under an imaging device at various orientations; having a bacterial endotoxin level below at least 20.0 EU/medical device.
However, Kubisen discloses [abstract] – “A method of packing organs of a subject, the method including accessing an interior cavity of the subject, repositioning the organs to provide a surgical space in the abdominal cavity, and positioning a non-fibrous body against the organs to provide a barrier between the organs and the surgical space.” [0024] – “For example, in one alternative embodiment, a non-fibrous body in accordance with embodiments of the present invention is a foam material, such as a foam wound dressing. In one such embodiment, the foam is an absorbent, open-celled foam, such as a silicone foam or an elastomeric foam.” [0032] – “In one specific arrangement, body 200 is formed from silicone foam or synthetic chamois.” [Claim 35] – “wherein the chamois is a silicone foam/synthetic chamois.” Kubisen teaches that an appropriate chamois material is silicone foam and discloses using the device in a surgical setting.
Additionally, Bengtson discloses [0010] – “Synthetic chamois can be made from, for example, polyvinyl alcohol, polyurethane, polyvinyl acetate, polypropylene, polyester, and polytetrafluoroethylene (PTFE), polyglycolic acid and other like-based materials. Other suitable materials, such as polyester, cellulose materials, micro denier or other cleaning textiles, foam like materials or fabrics may also be used.”
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the medical device of Bengtson to be made of open celled silicone foam as taught by Kubisen. A skilled artisan would have been motivated to do so because Kubisen teaches that silicone foam is absorbent and is beneficial as a non-fibrous material ([0024]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to surgical sponge-like devices.
As a result of the modification, Bengtson in view of Kubisen teaches an open celled foam material (In view of Korteweg, the material of Bengtson is a silicone foam which is expected to have similar properties to the synthetic chamois of Bengtson.).
Bengtson in view of Kubisen does not teach a plurality of radiopaque (RO) ink markers imbedded into a surface of the foam material such that the medical device is configured to be visible under an imaging device at various orientations; having a bacterial endotoxin level below at least 20.0 EU/medical device.
However, Southworth discloses a radiolucent implant with a set of evenly spaced parallel lines of radio-opaque material, such as wires, ink or powder that are embedded within, imprinted upon or adhered to a radiolucent body 104. See [0063].
Additionally, Bengtson discloses [0037] – “Each surgical sponge device 18 can incorporate a radio opaque marker or RFID to aid in the reconciliation of the sponge count before wound closure or to be seen on X-ray if there is a question of one being retained inside a body cavity.”
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to embed a set of evenly spaced parallel lines of radiopaque ink into the sponge device of Bengtson as taught by Southworth. A skilled artisan would have been motivated to do so because Southworth teaches the use of radiopaque ink to mark radiolucent devices within the body and Bengtson discloses that it is desired for a radiopaque material to be used to mark the sponge devices. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to medical devices inserted into the body having radiopaque materials.
As a result of the combination, Bengtson in view of Kubisen and Southworth teaches a plurality of radiopaque (RO) ink markers imbedded into a surface of the open-celled foam material configured to be visible under an imaging device at various orientations (In view of Southworth, a set of evenly spaced parallel lines of radiopaque ink are embedded within the surgical sponge of Bengtson.).
Bengtson in view of Kubisen and Southworth does not teach having a bacterial endotoxin level below at least 20.0 EU/medical device.
However, Kemnitzer discloses a pyrogen-free neurological sponge containing less than 0.45 EU/cm3 of bacterial endotoxins. Kemnitzer discloses a method of producing the surgical sponge comprising the steps of: (a) providing an absorbent material, wherein said absorbent material optionally contains bacterial endotoxins in a concentration of at least 0.45 EU/cm3 of absorbent material; and (b) forming the absorbent material into a sponge, provided that: (1) when the concentration of bacterial endotoxins in the absorbent material is at least 0.45 EU/cm3 of absorbent material, pyrogens are extracted from the absorbent material into a solvent before and/or after the forming step; and (2) when the concentration of bacterial endotoxins in the absorbent material is less than 0.45 EU/cm3 of absorbent material, the forming step is performed under pyrogen-free conditions and/or is followed by a pyrogen extraction step.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for a bacterial endotoxin level to be below 20.0 EU/device by following the method of removing bacterial endotoxins as taught by Kemnitzer. A skilled artisan would have been motivated to do so because Kemnitzer teaches that a low bacterial endotoxin level in each device prevents the buildup of endotoxins as more than one sponge are generally used in a given procedure. A device having 0.45 EU/cm3 can be up to 44.4 cm3 in size before having a bacterial endotoxin level of 20.0 EU and the device of Bengtson can be any size. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to surgical sponges.
As a result of the combination, Bengtson in view of Kubisen, Southworth and Kemnitzer teaches having a bacterial endotoxin level below at least 20.0 EU/medical device (In view of Kemnitzer, the bacterial endotoxin level is below 20.0 EU/device for device 44.4 cm3 in size and smaller.).
Regarding claim 58, Bengtson in view of Kubisen, Southworth and Kemnitzer teaches the method of claim 22, further comprising using the medical device to clean a surgical instrument or secondary medical device ([0040] – “The surgical sponge-pad device 18 can be sterilized during a surgical procedure and further be used for cleaning procedure, such as sterilizing the surgical equipment or operating table”).
Regarding claim 59, Bengtson in view of Kubisen, Southworth and Kemnitzer teaches the method of claim 58, further comprising the steps of: providing a second surgical medical device; applying a solution to the second surgical medical device to condition for use; manipulating the second conditioned medical device in the operating field to absorb one or more of blood, body fluids, water, and other fluids or materials at the operative site; returning the now-used second medical device to the conditioning liquid to clean and rinse it; and repeating as necessary ([0044] – “The unique functional features of each surgical sponge-pad device 18, as described, make possible a unique method of using only a limited number of surgical sponges during a given surgical procedure.” All of the methods applied to the first medical device are also performed to the second medical device of Bengtson.).
Regarding claim 61, Bengtson in view of Kubisen, Southworth and Kemnitzer teaches the method of claim 58, wherein the hydrophilic foam does not contain or include one or more of lint, cellulose, latex, bisphenol A (BPA), di(2-ethylhexyl)phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), and diisobutyl phthalate (DIBP) ([0008] – “Our device, however, is up to 1500% more absorbent, much more durable, lint and particle free, washable and reusable.”).
Claim(s) 60 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0079590 (Bengtson) in view of US 2012/0088958 (Kubisen et al.), US 2005/0246020 (Southworth) and US 2008/0177240 (Kemnitzer II et al.), and further in view of US 2020/0221976 (Hunt).
Regarding claim 60, Bengtson in view of Kubisen, Southworth and Kemnitzer teaches the method of claim 58, wherein the open-celled foam material comprises a hydrophilic open-celled foam material.
Bengtson in view of Kubisen, Southworth and Kemnitzer does not teach that the material is reticulated.
However, Hunt discloses a wound-filling matrix made of foam. The foam may be made from an open-celled reticulated silicone material. See [0053].
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to make the material of Bengtson in view of Kubisen reticulated as taught by Hunt. A skilled artisan would have been motivated to do so because Hunt teaches reticulated foam as a preferred material for a wound filler and reticulated foam is known in the art to increase breathability and surface area of the foam. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to medical devices that are inserted into the human body.
As a result of the modification, Bengtson in view of Kubisen, Southworth, Kemnitzer and Hunt teaches that the material is reticulated (In view of hunt, the material is an open-celled reticulated silicone foam material.).
Conclusion
The following prior art made of record and not relied upon are considered pertinent to
applicant's disclosure.
US 2014/0194733 (Goforth et al.)
US 4,098,728 (Rosenblatt)
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/SETH R. BROWN/Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786