DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-6, 8-12, and 15-24 currently pending. Claims 7 and 13-14 have been cancelled. Claims 15-21 remain withdrawn from consideration pertaining to the previously set forth election/restriction requirement.
Response to Arguments
Applicant's arguments filed January 23rd, 2026 included in the Pre-Appeal Brief Conference request have been fully considered and the 102 rejection, as well as the Finality of the Final rejection mailed on October 23rd, 2025 has herein been withdrawn in response to the findings of the Pre-Appeal Brief Conference.
While applicant’s arguments are seen as sufficient to overcome the 102 rejection as detailed in the Final rejection, the newly presented 103 rejection below is seen to render the “sterile” claim limitation to have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
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.
Claim 24 is 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 24 recites the limitation "the one-or-more antimicrobial agents" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the examiner is under the assumption that the one-or-more antimicrobial agents are those presented in claim 23 and as such is treating claim 24 as if dependent upon claim 23 rather than claim 22 as claim 23 is seen to present one-or more antimicrobial agents.
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, 3, 4, 6. 8, and 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vorhees (U.S. Publication 2017/0189225) in view of Augustine (U.S. Patent No. 5,947,914) and Hoover (U.S. Patent No. 10,610,424).
Regarding claim 1, Voorhees discloses a pad 10 for targeted temperature management, comprising:
A multilayered pad body (Fig. 2) including:
a conduit layer (14 and 15 ¶0052 fluid circulation layer) including one or more conduits (¶0035 fluid channels) configured to convey a fluid through the conduit layer (¶0035 direct fluid flow ¶0053 through fluidly interconnected medical pad);
An impermeable film 15 over the conduit layer configured to retain the fluid in the conduit layer when the fluid is conveyed through the conduit layer; and
A thermally conductive wound-healing layer 16 over the impermeable film configured for placement on a portion of a patient’s body (¶0007, placed on a patient’s body); and
A backing 17 over the wound-healing layer in a ready-to-use state of the pad, the backing configured to cover the wound-healing layer prior to use of the pad (¶0033 cover adhesive surface prior to use).
Voorhees does not expressly disclose the placement being on a wounded portion of a patient’s body including a burn wound; the wound-healing layer being sterile; or the backing layer therefore maintaining sterility.
Regarding the limitation of the wound-healing layer being sterile and the backing layer maintaining sterility, Augustine, in the same field of endeavor of thermal wound coverings (Title: wound covering, Abstract active heat transfer) discloses a backing layer 74 spanning an entire lower surface of the covering to maintain the sterility of the treatment volume (Col. 4 lines 31-39 release liner may span the entire lower surface of the covering to maintain the sterility of the treatment volume).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wound-healing layer and backing layer of Voorhees to have been sterile and maintained sterility as taught by Augustine for the purpose of providing a sterile environment to the wound through the covering which would have the benefit of preventing introduction of micro-organisms such as bacteria that cause disease and further aggravation of the wound.
Furthermore, Hoover, in the same field of endeavor of wound contacting medical devices, teaches in Col 1 lines 22-50 that the production of wound contacting medical devices to be sterile is well known in the field (Col. 1 lines 22-50 most modern bandages are produced in a sterile environment and individual wrapped to protect and preserve each bandage) and providing the benefits of reducing introduction of bacteria, especially those that have developed resistance to most or even all of the known antibiotic treatments (Col. 1 lines 22-50).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modified the wound-healing layer and backing layer of Voorhees to have been sterile and maintained sterility as taught by Augustine for the purpose of providing the benefits of reducing introduction of bacteria, especially those that have developed resistance to most or even all of the known antibiotic treatments (Col. 1 lines 22-50 of Hoover), as taught by Hoover to be a well known technique in the art to incorporate into medical devices that are to come in contact with a patient.
Regarding the limitation of “on a wounded portion of a patient’s body including a burn wound”, the limitations of “on a wounded portion of a patient’s body including a burn wound”, is considered functional language (placement on a wounded portion including a burn wound describes the placement of the device by the user of the device and thus the function of use of the device). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Voorhees in view of Augustine and Hoover suggests all the structure as claimed, and is further placed onto a patient (¶0007). As such, it is capable of performing the functions as claimed (i.e., it is capable of being placed on a wound including a burn wound).
Regarding claim 3, Voorhees in view of Augustine and Hoover suggest the pad of claim 1. Voorhees further disclose the wound-healing layer 16 being chemically stable to sterilization via ultraviolet light (¶0014 ultra-violet light-cured composition cross-links under ultraviolet light to final product and therefore is functionally stable to ultraviolet light, see above rejection of claim 1 regarding functional claim limitations).
Regarding claim 4, Voorhees in view of Augustine and Hoover suggest the pad of claim 1. Voorhees does not expressly disclose the wound-healing layer being configured for healing a heat burn, a friction burn, an electrical burn, a radiation burn, or frostbite as the burn wound.
However, the limitations of “configured for healing a heat burn, a friction burn, an electrical burn, a radiation burn, or frostbite as the burn” is considered functional language (described the use of the product with regard to patient treatment). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Voorhees discloses all the structure as claimed, and is further placed onto a patient (¶0007). As such, it is capable of performing the functions as claimed (i.e., it is capable of being placed on a wound including a burn wound and healing a heat burn, a friction burn, an electrical burn, a radiation burn, or frostbite as the burn).
Regarding claim 6, Voorhees in view of Augustine and Hoover suggest the pad of claim 1. Voorhees further discloses the pad further comprising an inlet 12a configured for charging the conduit layer with the supply fluid (¶0031 interconnection with fluid circulation lines, fluid circulation lines connect to fluid conditioning assembly 23) and an outlet 12b configured for discharging the return fluid from the conduit layer (¶0031 interconnection with fluid circulation lines, fluid circulation lines connect to fluid conditioning assembly 23).
Regarding claim 8, Voorhees discloses a system for targeted temperature management ("TTM"), comprising:
a control module (Fig. 7 elements 50 and 23) including a hydraulic system 23 having:
a chiller evaporator 234 configured for fluid cooling (¶0055 yield cooling of fluid);
a heater 229 configured for fluid heating (¶0059 selective heating of fluid),
the chiller evaporator 234 and the heater 229, together, configured to provide a temperature-controlled fluid (¶0057 and 0059 heater and chiller both receive output signals 52 from controller to control degree of heating or cooling);
one or more outlets 34 configured for discharging the temperature-controlled as a supply fluid from the hydraulic system (¶0053 through outlet line, through an outlet port, through the fluidly interconnected medical pad); and
one or more inlets 33 configured for charging the hydraulic system with a return fluid to continue to produce the temperature-controlled fluid (¶0053 after through medical pad, through inlet port, and through inlet line 28); and
a pad 10 including:
a multilayered pad body (Fig. 2) including:
a conduit layer (14 and 15 ¶0052 fluid circulation layer) including one or more conduits (¶0035 fluid channels) configured to convey the supply fluid through the conduit layer (¶0035 direct fluid flow ¶0053 through fluidly interconnected medical pad);
an impermeable film 15 over the conduit layer configured to retain the supply fluid in the conduit layer when the supply fluid is conveyed through the conduit layer (¶0032 interconnected with 14 to define fluid circulation layer with internal volume); and
a thermally conductive wound-healing layer 16 over the impermeable film 15 configured for placement on a wounded portion of a patient's body (¶0007, placed on a patient’s body); and
a backing 17 over the wound-healing layer in a ready-to-use state of the pad, the backing configured to cover the wound-healing layer prior to use of the pad (¶0033 cover adhesive surface prior to use).
Voorhees does not expressly disclose the placement being on a wounded portion of a patient’s body including a burn wound; the wound-healing layer being sterile; or the backing layer therefore maintaining sterility.
Regarding the limitation of the wound-healing layer being sterile and the backing layer maintaining sterility, Augustine, in the same field of endeavor of thermal wound coverings (Title: wound covering, Abstract active heat transfer) discloses a backing layer 74 spanning an entire lower surface of the covering to maintain the sterility of the treatment volume (Col. 4 lines 31-39 release liner may span the entire lower surface of the covering to maintain the sterility of the treatment volume).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wound-healing layer and backing layer of Voorhees to have been sterile and maintained sterility as taught by Augustine for the purpose of providing a sterile environment to the wound through the covering which would have the benefit of preventing introduction of micro-organisms such as bacteria that cause disease and further aggravation of the wound.
Furthermore, Hoover, in the same field of endeavor of wound contacting medical devices, teaches in Col 1 lines 22-50 that the production of wound contacting medical devices to be sterile is well known in the field (Col. 1 lines 22-50 most modern bandages are produced in a sterile environment and individual wrapped to protect and preserve each bandage) and providing the benefits of reducing introduction of bacteria, especially those that have developed resistance to most or even all of the known antibiotic treatments (Col. 1 lines 22-50).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modified the wound-healing layer and backing layer of Voorhees to have been sterile and maintained sterility as taught by Augustine for the purpose of providing the benefits of reducing introduction of bacteria, especially those that have developed resistance to most or even all of the known antibiotic treatments (Col. 1 lines 22-50 of Hoover), as taught by Hoover to be a well-known technique in the art to incorporate into medical devices that are to come in contact with a patient.
Regarding the limitation of “on a wounded portion of a patient’s body including a burn wound”, the limitations of “on a wounded portion of a patient’s body including a burn wound”, is considered functional language (placement on a wounded portion including a burn wound describes the placement of the device by the user of the device and thus the function of use of the device). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Voorhees in view of Augustine and Hoover suggests all the structure as claimed, and is further placed onto a patient (¶0007). As such, it is capable of performing the functions as claimed (i.e., it is capable of being placed on a wound including a burn wound).
Regarding claim 10, Voorhees in view of Augustine and Hoover suggest the system of claim 8. Voorhees further discloses the wound-healing layer 16 being chemically stable to sterilization via ultraviolet light (¶0014 ultra-violet light-cured composition cross-links under ultraviolet light to final product and therefore is functionally stable to ultraviolet light, see above rejection of claim 8 regarding functional claim limitations).
Regarding claim 11, Voorhees in view of Augustine and Hoover suggest the system of claim 8. Voorhees does not expressly disclose the wound-healing layer being configured for healing a heat burn, a friction burn, an electrical burn, a radiation burn, or frostbite as the burn wound.
However, the limitations of “configured for healing a heat burn, a friction burn, an electrical burn, a radiation burn, or frostbite as the burn” is considered functional language (described the use of the product with regard to patient treatment). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Voorhees discloses all the structure as claimed, and is further placed onto a patient (¶0007). As such, it is capable of performing the functions as claimed (i.e., it is capable of being placed on a wound including a burn wound and healing a heat burn, a friction burn, an electrical burn, a radiation burn, or frostbite as the burn).
Claim(s) 2, 9, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vorhees (U.S. Publication 2017/0189225) in view of Augustine (U.S. Patent No. 5,947,914), Hoover (U.S. Patent No. 10,610,424), and Manion et al. (U.S. Publication 2015/0209192).
Regarding claim 2, Voorhees in view of Augustine and Hoover suggest the system of claim 1. Voorhees further discloses the wound-healing layer 16 of the pad 10 including a hydrogel (¶0032 hydrogel).
Voorhees does not expressly disclose the hydrogel being selected from a poly(ethylene glycol) hydrogel, an alginate-based hydrogel, a chitosan-based hydrogel, a collagen-based hydrogel, a dextran-based hydrogel, a hyaluronan- based hydrogel, a xanthan-based hydrogel, a konjac-based hydrogel, a gelatin-based hydrogel, and a combination of two or more of the foregoing hydrogels.
However, Manion, in the same field of endeavor of patient temperature management of wound site (Abstract, reduce temperature at a surgical site), discloses including a hydrogel ¶0027 where the network material is selected from chitosan, hyaluronic acid (hyaluronan), or alginate (¶0027 may be a network of hydrophilic polymer chains, chitosan, hyaluronic acid, alginate or combination thereof).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the network of polymers of the hydrogel of Voorhees that performs the function of acting as a hydrogel for the network of polymers including one of chitosan, hyaluronic acid or alginate of Manion et al. since these elements perform the same function of acting as a hydrogel. Simply substituting one hydrogel means for another would yield the predictable result of allowing a(n) layer to function as a hydrogel. See MPEP 2143.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the main body of Trinder out of rubber, 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.
Regarding claim 9, Voorhees in view of Augustine and Hoover suggest the system of claim 8. Voorhees further discloses the wound-healing layer 16 of the pad 10 including a hydrogel (¶0032 hydrogel).
Voorhees does not expressly disclose the hydrogel being selected from a poly(ethylene glycol) hydrogel, an alginate-based hydrogel, a chitosan-based hydrogel, a collagen-based hydrogel, a dextran-based hydrogel, a hyaluronan- based hydrogel, a xanthan-based hydrogel, a konjac-based hydrogel, a gelatin-based hydrogel, and a combination of two or more of the foregoing hydrogels.
However, Manion, in the same field of endeavor of patient temperature management of wound site (Abstract, reduce temperature at a surgical site), discloses including a hydrogel ¶0027 where the network material is selected from chitosan, hyaluronic acid (hyaluronan), or alginate (¶0027 may be a network of hydrophilic polymer chains, chitosan, hyaluronic acid, alginate or combination thereof).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the network of polymers of the hydrogel of Voorhees that performs the function of acting as a hydrogel for the network of polymers including one of chitosan, hyaluronic acid or alginate of Manion et al. since these elements perform the same function of acting as a hydrogel. Simply substituting one hydrogel means for another would yield the predictable result of allowing a(n) layer to function as a hydrogel. See MPEP 2143.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the main body of Trinder out of rubber, 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.
Regarding claim 22, Voorhees in view of Augustine and Hoover suggest the pad of claim 1. Voorhees further discloses the wound-healing layer 16 of the pad 10 conformably adhering to the wounded portion of the patient’s body for thermal conduction (¶0032 flexible hydrogel layer presents an adhesive surface to establish and maintain intimate contact with a skin region of a patient so as to optimize thermal exchange, flexibility of hydrogel layer along with establishment of intimate contact show conformability to skin region of patient) including a hydrogel (¶0032 hydrogel).
Voorhees does not expressly disclose the hydrogel being selected from a poly(ethylene glycol) hydrogel, an alginate-based hydrogel, a chitosan-based hydrogel, a collagen-based hydrogel, a dextran-based hydrogel, a hyaluronan- based hydrogel, a xanthan-based hydrogel, a konjac-based hydrogel, a gelatin-based hydrogel, and a combination of two or more of the foregoing hydrogels.
However, Manion, in the same field of endeavor of patient temperature management of wound site (Abstract, reduce temperature at a surgical site), discloses including a hydrogel ¶0027 where the network material is selected from chitosan, hyaluronic acid (hyaluronan), or alginate (¶0027 may be a network of hydrophilic polymer chains, chitosan, hyaluronic acid, alginate or combination thereof).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the network of polymers of the hydrogel of Voorhees that performs the function of acting as a hydrogel for the network of polymers including one of chitosan, hyaluronic acid or alginate of Manion et al. since these elements perform the same function of acting as a hydrogel. Simply substituting one hydrogel means for another would yield the predictable result of allowing a(n) layer to function as a hydrogel. See MPEP 2143.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the main body of Trinder out of rubber, 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.
Voorhees in view of Manion do not expressly disclose or suggest the adherence occurring without wounding the wounded portion of the patient’s body upon removal of the pad. However, the limitations of “without wounding the wounded portion of the patient’s body upon removal of the pad” is considered functional language (described function of the device to be removable from the skin in such a way that does not damage the patient). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Voorhees in view of Manion suggest all the structure as claimed, and is further easy to remove and does not require extensive hygienic patient clean-up after removal suggesting that the hydrogel layer does not leave a lasting adhesive interaction between the pad and the patient. As such, it is capable of performing the functions as claimed (i.e. it is capable of being functionally removed without wounding the wounded portion of the patient’s body upon removal of the pad).
Claim(s) 5 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voorhees et al. (U.S. Publication 2017/0189225) in view of Augustine (U.S. Patent No. 5,947,914), Hoover (U.S. Patent No. 10,610,424), and Tawil et al. (U.S. Patent No. 11,173,071).
Regarding claim 5, Voorhees in view of Augustine and Hoover suggest the pad of claim 1. Voorhees does not expressly disclose the wound-healing layer including one or more antimicrobial agents selected from an aminoglycoside including neomycin, kanamycin, gentamycin, or tobramycin; a cyclic peptide including polymyxin B or polymyxin E; a sulfonamide including mafenide acetate or silver sulfadiazine; a tetracycline including doxycycline or minocycline; a cationic steroid antimicrobial ("CSA") including CSA-8; a metal- based antimicrobial including an organometallic compound including silver sulfadiazine, an elemental metal including a preparation of silver or copper nanoparticles, a metal oxide including a preparation of zinc-oxide nanoparticles, or a salt including silver nitrate, a Cu(II) salt, or a Ga(III) salt; a halogen-based antimicrobial including a diatomic halogen molecule including iodine, a halophor including iodopovidone, or a salt including sodium hypochlorite; chlorhexidine; vancomycin; fusidic acid; usnic acid; bacitracin; mupirocin; nitrofurazone; nystatin; rifampicin; and a biofilm-disrupting agent including a 2-aminobenzimidazole or a D- amino acid.
However, Tawil, in the same field of endeavor of wound treatment (Col. 1 lines 15-25 wound dressings for wound healing), teaches a hydrogel including bacitracin (Col. 3 lines 16-27, the hydrogel includes bacitracin) for the purpose of adding an antibacterial that acts as a safeguard to minimize bacterial contamination of the wound location (Col. 3 lines 28-37).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the hydrogel of Voorhees to have included bacitracin as taught by Tawil, when utilize the device in wound treatment for the purpose of adding an antibacterial that acts as a safeguard to minimize bacterial contamination of the wound location (Col. 3 lines 28-37).
Regarding claim 12, Voorhees in view of Augustine and Hoover suggest the system of claim 8. Voorhees does not expressly disclose the wound-healing layer including one or more antimicrobial agents selected from an aminoglycoside including neomycin, kanamycin, gentamycin, or tobramycin; a cyclic peptide including polymyxin B or polymyxin E; a sulfonamide including mafenide acetate or silver sulfadiazine; a tetracycline including doxycycline or minocycline; a cationic steroid antimicrobial ("CSA") including CSA-8; a metal- based antimicrobial including an organometallic compound including silver sulfadiazine, an elemental metal including a preparation of silver or copper nanoparticles, a metal oxide including a preparation of zinc-oxide nanoparticles, or a salt including silver nitrate, a Cu(II) salt, or a Ga(III) salt; a halogen-based antimicrobial including a diatomic halogen molecule including iodine, a halophor including iodopovidone, or a salt including sodium hypochlorite; chlorhexidine; vancomycin; fusidic acid; usnic acid; bacitracin; mupirocin; nitrofurazone; nystatin; rifampicin; and a biofilm-disrupting agent including a 2-aminobenzimidazole or a D- amino acid.
However, Tawil, in the same field of endeavor of wound treatment (Col. 1 lines 15-25 wound dressings for wound healing), teaches a hydrogel including bacitracin (Col. 3 lines 16-27, the hydrogel includes bacitracin) for the purpose of adding an antibacterial that acts as a safeguard to minimize bacterial contamination of the wound location (Col. 3 lines 28-37).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the hydrogel of Voorhees to have included bacitracin as taught by Tawil, when utilize the device in wound treatment for the purpose of adding an antibacterial that acts as a safeguard to minimize bacterial contamination of the wound location (Col. 3 lines 28-37).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voorhees et al. (U.S. Publication 2017/0189225) Augustine (U.S. Patent No. 5,947,914), Hoover (U.S. Patent No. 10,610,424), Manion et al. (U.S. Publication 2015/0209192) and Tawil et al. (U.S. Patent No. 11,173,071).
Regarding claim 23, Voorhees in view of Augustine, Hoover, and Manion suggest the pad of claim 22. Voorhees does not expressly disclose the wound-healing layer including one or more antimicrobial agents selected from an aminoglycoside including neomycin, kanamycin, gentamycin, or tobramycin; a cyclic peptide including polymyxin B or polymyxin E; a sulfonamide including mafenide acetate or silver sulfadiazine; a tetracycline including doxycycline or minocycline; a cationic steroid antimicrobial ("CSA") including CSA-8; a metal- based antimicrobial including an organometallic compound including silver sulfadiazine, an elemental metal including a preparation of silver or copper nanoparticles, a metal oxide including a preparation of zinc-oxide nanoparticles, or a salt including silver nitrate, a Cu(II) salt, or a Ga(III) salt; a halogen-based antimicrobial including a diatomic halogen molecule including iodine, a halophor including iodopovidone, or a salt including sodium hypochlorite; chlorhexidine; vancomycin; fusidic acid; usnic acid; bacitracin; mupirocin; nitrofurazone; nystatin; rifampicin; and a biofilm-disrupting agent including a 2-aminobenzimidazole or a D- amino acid.
However, Tawil, in the same field of endeavor of wound treatment (Col. 1 lines 15-25 wound dressings for wound healing), teaches a hydrogel including bacitracin (Col. 3 lines 16-27, the hydrogel includes bacitracin) for the purpose of adding an antibacterial that acts as a safeguard to minimize bacterial contamination of the wound location (Col. 3 lines 28-37).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the hydrogel of Voorhees to have included bacitracin as taught by Tawil, when utilize the device in wound treatment for the purpose of adding an antibacterial that acts as a safeguard to minimize bacterial contamination of the wound location (Col. 3 lines 28-37).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voorhees et al. (U.S. Publication 2017/0189225) Augustine (U.S. Patent No. 5,947,914), Hoover (U.S. Patent No. 10,610,424), Manion et al. (U.S. Publication 2015/0209192), and Tawil et al. (U.S. Patent No. 11,173,071) as evidenced by Lustig and Peppas (Solute Diffusion in Swollen Membranes, Journal of Applied Polymer Science Volume 36, Issue 4 Pages 735-981, Published August 1988; see included NPL).
Regarding claim 24, Voorhees in view of Augustine, Hoover, Manion, and Tawil suggest the pad of claim 23. Voorhees in view of Tawil do not expressly disclose or suggest a temperature of the fluid modulating delivery rates by either increasing or decreasing a delivery rate of an antimicrobial agent of the one-or-more antimicrobial agents to the wounded portion of the patient’s body.
However, the limitations of “a temperature of the fluid modulates delivery rates by either increasing or decreasing a delivery rate of an antimicrobial agent of the one-or-more antimicrobial agents to the wounded portion of the body” is considered functional language (based on Paragraph 0057 of Applicant’s specification indicating that temperature of the supply fluid functions to increase or decrease the rate of delivery of the substance from the wound-healing layer to the wounded portion of the patient’s body). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Voorhees and Tawil suggest all the structure as claimed, and further capable of controlling the temperature of the circulating fluid (¶0020 controlling a temperature of the circulating fluid). The delivery of the antimicrobial bacitracin occurs through the diffusion of bacitracin from the hydrogel to the patient. Diffusion of a substance through a hydrogel is inherently increased or decreased in a proportional manner to the temperature of the hydrogel, as evidenced by Lustig and Peppas (see annotated attached document page 739 describing relationship of temperature to diffusion rate of solutes through gel substance). As such, the device suggested by Voorhees in view of Tawil would inherently perform the functions as claimed (i.e. hydrogel diffusion rate is inherently affected by the temperature of the hydrogel which would be affected by the temperature of the fluid).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER DANIEL SMITH whose telephone number is (571)272-8564. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
