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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 11 and 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 11 and 19 recite recommendations of the American Burn Association. However, formal recommendations are not provided in the specification referencing a publication title, date, and source that would provide guidance as to the what the recommendations are and when the recommendations were created or published. The guidelines for burn protocols are many and fluid depending on the situation, severity of burn, age and condition of the victim and the guidelines may change over time. Therefore, a person of ordinary skill in the art would not recognize in the disclosure a description of the invention defined by the claims. To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. An applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). MPEP 2163.I and 2163.3
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 9-11 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 9 recites the limitation "micro-chemical debridement" in line 4. There is insufficient antecedent basis for this limitation in the claim. Claims 10 and 11 depend from claim 9.
Claims 11 and 19 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.
Claims 11 and 19 recite the limitation "following recommendations of the American Burn Association". There is insufficient antecedent basis for this limitation in the claim. Additionally, the recommendations are too broad and no written description is provided in the specification to support the recommendations. The claims are indefinite since the recommendation are not formally provided in the specification and the scope of the claims is unclear since one cannot ascertain the steps of the recommendations.
It is suggested that Applicant consider cancelling claims 11 and 19 since the specification does not support the claimed subject matter. The specification can not be amended to include support the limitations, as such an amendment would introduce new matter into the disclosure of the invention.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Perry US Patent Application Publication 2021/0228786 in view of Stiehl et al. WO 2019/094136.
As to claim 1, Perry teaches a system for treating a burn wound caused by a burning trauma (para. 0026), the system comprising: a Hydrodynamic Dressing (HD) – where Perry teaches that upon the application of a larger amount of pressure (such as from the pump or related irrigation fluid delivery source 121), this fluid could be expelled more as a stream, jet or other higher throughput (Perry para. 0035). Perry teaches the HD comprises a 130, sponge 150, packing 105, or gauze 107 (Figs. 2, 5; paras. 0029, 0034, 0050) configured and adapted to enclose the burn wound 10;
Perry teaches the system comprises distinct Therapeutic Fluids (TFs) – where Perry teaches 1) saline fluid for irrigation (paras. 0034, 0050), 2) anti-microbial solution of choice for a reduction in microorganisms (paras. 0034, 0064). Perry teaches when soaking the wound bed in fluid, improved wound moisture maintenance, irrigation debridement, physical disruption of biofilm, and removal of microorganisms may be achieved (Perry para. 0043). Perry teaches some fluids for irrigation and reduction of microorganisms as discussed above, but does not specifically teach three distinct fluids formulated to support a designated stage of healing with respect to the burn wound. Stiehl, from the same field of endeavor, teaches a wound healing system involving wound debridement using a pulsatile flow of fluid to debride the wound and remove foreign biomass produced by bacteria (Stiehl para. 005). Stiehl teaches fluids used in the wound treatment include a chlorhexidine gluconate material that is used in irrigation using a continuous flow of irrigating fluid to the surface of the wound for debridement and removal of the detritus (para. 00113). It would have been obvious to one having ordinary skill in the art to use a therapeutic debriding agent taught in Stiehl in the wound healing system of Perry. Doing so would allow removal of necrotic tissue and microbial biofilms to create an optimal environment for healing and reduce the risk of infection.
Perry/Stiehl teach an Automated Fluid Delivery System (AFDS) configured and adapted to deliver each of the three TFs, respectively, to the burn wound enclosed within the HD at a respectively specified time (Perry para. 0043; Stiehl paras.005, 00113), temperature (Perry para. 0058), pressure (Perry paras. 0033, 0035; 0037), and flow rate (Perry para. 0033) according to a burn wound treatment protocol.
As to claim 2, Perry/Stiehl teach the HD comprises a wound enclosure that isolates the wound from the nosocomial environment, facilitates wound observation, and facilitates hydrodynamic debridement – where Stiehl teaches a sterile bag that encloses the wound with a flexible tube and pump outside the sterile field with its nozzle inside the sterile field, where the solution is pressurized inside the tube to the preferred irrigation device and sprayed through its nozzle onto the wound site, thereby avoiding any direct contact of the solution outside the tube with the pump structures (Stiehl para. 0049). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to modify Perry with a sterile wound enclosure as taught in Stiehl so the wound is not contaminated in the irrigating process.
Claims 3-14 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Perry US Patent Application Publication 2021/0228786 in view of Stiehl et al. WO 2019/094136 and further in view of Locke et al. US Patent Application Publication 2021/0060217.
As to claim 3, Perry/Stiehl teach the AFDS comprises an automated conditioning and pumping unit that is configured and adapted to deliver each of the three TFs, respectively (Perry para. 0051; Stiehl paras.005, 00113), to the burn wound enclosed within the HD. Perry/Stiehl do not specifically teach the three TF’s delivered in sequence. Locke teaches a therapy system for treating a tissue site with negative-pressure therapy and/or fluid instillation therapy in response to information received from a diagnostic unit (Locke, Abstract). Locke teaches the fluid therapy may comprise one or more sources of therapeutic compounds 114 (Locke Fig. 2) that may vary according to a prescribed therapy. Locke teaches examples of solutions that may be suitable for some prescriptions include hypochlorite-based solutions, silver nitrate (0.5%), sulfur-based solutions, biguanides, cationic solutions, and isotonic solutions (Locke para. 0047). Locke teaches the therapy system 100 may further include additional sources of solution or treatment compounds or substances, in addition to the solution source 114. For example, the therapy system 100 may include a first treatment source 160 and a second treatment source 162, both of which may be in fluid connection with the solution source 114. Locke teaches each of the first treatment source 160 and the second treatment source 162 may include one or more compounds that may be delivered to the tissue site for therapeutic purposes. Locke teaches in operation, as instillation fluid is being conducted from the solution source 114 to the dressing 102, additional therapeutic compounds from either or both of the first treatment source 160 and the second treatment source 162 may be added to the instillation fluid. Lock teaches additional treatment sources (not shown), may also be included in the therapy system 100, which may include additional treatment compounds for delivering to the tissue site (Locke para. 0056). As to the sequential delivery of fluids, Locke teaches the therapy system may be used in accordance with an operating method (Fig. 9) that senses various parameters to activate negative pressure or fluid therapy. Whether or not the measured parameters are in an acceptable range determines if the system adjusts fluid installation, and/or adjust additional treatment compounds (Locke Fig. 9; paras. 0093-0094). The therapy system of Locke essentially provides one or more therapeutic fluids in sequence in response to received data from the controller. Locke teaches it may be challenging for clinicians to recognize conditions, such as infection, at a tissue site undergoing negative pressure or fluid instillation therapy. Locke teaches by providing a therapy system that incorporates real-time diagnostic feedback with respect to parameters at a tissue site, clinicians may be better alerted to developing or changing conditions at the tissue site (Locke para. 0095) It would have been obvious to one having ordinary skill in the art before the invention was originally filed to provide the therapeutic fluid in sequence in response to conditions at the tissue site for the benefits taught in Locke.
Perry/Stiehl/Locke teach the fluids are delivered at specified flow rates (Perry paras. 0045-0046), pressures (Perry paras. 0045-0046), and temperatures (Perry para. 0058).
As to claim 4, Perry/Stiehl/Locke teach the HD comprises a nozzle configured and adapted to deliver one or more of the three distinct TFs at a measured rate to facilitate the removal of toxins and necrotic byproducts from the burn wound – where Stiehl teaches a generally wedge shaped nozzle which has an effective diameter that determines a generally flat spray pattern coinciding with a contour of the wound (Stiehl paras. 0029, 0034, 0032). Stiehl teaches the system for irrigation comprises a nozzle, a tube attached to the nozzle, and clear plastic tubular containment and collection bag having a fenestration (Stiehl Fig. 6). Lateral flow of effluent, from the spray pattern of the nozzle, is collected in the bag for disposal (Stiehl para. 0034-0035). Additionally, Locke teaches a wound cover 106 providing a seal adequate to maintain a negative pressure at a tissue site and vapor permeable, but impermeable to liquid (Locke Fig. 2; para. 0042).
As to claim 5, Perry/Stiehl/Locke teach the HD comprises a distributed array of nozzles 141 (Perry Figs. 7A, 7B para. 0053), each respective nozzle configured and adapted to deliver one or more of the three distinct TFs at a measured rate to facilitate the removal of toxins and necrotic byproducts from the burn wound (Perry Figs. 7A, 7B; paras. 0031, 0053).
As to claim 6, Perry/Stiehl/Locke teach the HD comprises an outlet port 161,162, 164 (Perry Figs. 3A), configurable to route fluids that pass across the burn wound 10 enclosed within the HD to either a waste receptacle or a recirculating pump 122 (Perry Fig. 2; para. 0028). Perry also teaches the apertures 145 in the delivery conduit 141, 140 allow for the dripping, spraying, or seepage of solutions and related fluids into one or more wound beds 110 (Perry para. 0034), which allows a reduction in dwell time needed for the irrigation fluid to reach the wound bed and avoids the conventional approaches of having the fluid travel through a substantially or even full thickness of the sponge 150, packing 105, or gauze 107.
As to claims 7-9, the claims are directed to a wound healing procedure. Claims 7-9 are specifically directed to the function of the therapeutic fluids. The structure and materials used in the combination of Perry, Stiehl, and Locke are the same as the therapeutic fluids of the present invention and used in a hydrodynamic wound therapy system as described in the rejections of claims 1-3 above. 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. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997). “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) (emphasis in original). In this case, since Perry/Stiehl/Locke comprise therapeutic fluids for use in wound healing and are capable of functioning in the manner as recited in claims 7-9. Since structural limitations are met by the references, it may be reasonably concluded that any function that will occur will be inherent which satisfies a prima facie case of obviousness. “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). MPEP 2112.01(I.)
As to claims 10 and 11 are directed to a burn wound treatment protocol. The structure of the wound treatment systems – i.e. nozzle, waste container, pressurized fluids, and materials used in the combination of Perry, Stiehl, and Locke are the same as the therapeutic fluids of the present invention and used in a hydrodynamic wound therapy system as described in the rejections of claims 1-3 above. 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. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997). “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) (emphasis in original). In this case, since Perry/Stiehl/Locke comprise a wound treatment system using therapeutic fluids for use in wound healing and are capable of functioning in the manner as recited in claims 10 and 11. Since structural limitations are met by the references, it may be reasonably concluded that any function that will occur will be inherent which satisfies a prima facie case of obviousness. “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). MPEP 2112.01(I.)
As to claim 12, Perry teaches a method of treating a burn wound caused by a burning trauma (para. 0026), the system comprising: a Hydrodynamic Dressing Pouch (HD) – where Perry teaches that upon the application of a larger amount of pressure (such as from the pump or related irrigation fluid delivery source 121), this fluid could be expelled more as a stream, jet or other higher throughput (Perry para. 0035). Perry teaches the HD comprises a 130, sponge 150, packing 105, or gauze 107 (Figs. 2, 5; paras. 0029, 0034, 0050) configured and adapted to enclose the burn wound 10;
Perry teaches the system comprises distinct Therapeutic Fluids (TFs) – where Perry teaches 1) saline fluid for irrigation (paras. 0034, 0050), 2) anti-microbial solution of choice for a reduction in microorganisms (paras. 0034, 0064). Perry teaches when soaking the wound bed in fluid, improved wound moisture maintenance, irrigation debridement, physical disruption of biofilm, and removal of microorganisms may be achieved (Perry para. 0043). Perry teaches some fluids for irrigation and reduction of microorganisms as discussed above, but does not specifically teach three distinct fluids formulated to support a designated stage of healing with respect to the burn wound. Stiehl, from the same field of endeavor teaches a wound healing system involving wound debridement using a pulsatile flow of fluid to debride the wound and remove foreign biomass produced by bacteria (Stiehl para. 005). Stiehl teaches fluids used in the wound treatment include a chlorhexidine gluconate material that is used in irrigation using a continuous flow of irrigating fluid to the surface of the wound for debridement and removal of the detritus (para. 00113). It would have been obvious to one having ordinary skill in the art to use a therapeutic debriding agent taught in Stiehl in the wound healing system of Perry. Doing so would allow removal of necrotic tissue and microbial biofilms to create an optimal environment for healing and reduce the risk of infection.
Perry/Stiehl teach an Automated Fluid Delivery System (AFDS) comprising a wound enclosure that isolates the wound from the nosocomial environment, facilitates wound observation, and facilitates hydrodynamic debridement – where Stiehl teaches a sterile bag that encloses the wound with a flexible tube and pump outside the sterile field with its nozzle inside the sterile field, where the solution is pressurized inside the tube to the preferred irrigation device and sprayed through its nozzle onto the wound site, thereby avoiding any direct contact of the solution outside the tube with the pump structures (Stiehl para. 0049). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to modify Perry with a sterile wound enclosure as taught in Stiehl so the wound is not contaminated in the irrigating process.
Perry/Stiehl teaches an Automated Fluid Delivery System (AFDS) configured and adapted to deliver each of the three TFs, respectively, to the burn wound enclosed within the HD at a respectively specified time (Perry para. 0043; Stiehl paras.005, 00113), temperature (Perry para. 0058), pressure (Perry paras. 0033, 0035; 0037), and flow rate (Perry para. 0033) according to a burn wound treatment protocol.
As to claim 13, Perry/Stiehl teach the AFDS comprises an automated conditioning and pumping unit that is configured and adapted to deliver each of the three TFs, respectively (Perry para. 0051; Stiehl paras.005, 00113), to the burn wound enclosed within the HD. Perry/Stiehl do not specifically teach the three TF’s delivered in sequence. Locke teaches a therapy system for treating a tissue site with negative-pressure therapy and/or fluid instillation therapy in response to information received from a diagnostic unit (Locke, Abstract). Locke teaches the fluid therapy may comprise one or more sources of therapeutic compounds 114 (Locke Fig. 2) that may vary according to a prescribed therapy. Locke teaches examples of solutions that may be suitable for some prescriptions include hypochlorite-based solutions, silver nitrate (0.5%), sulfur-based solutions, biguanides, cationic solutions, and isotonic solutions (Locke para. 0047). Locke teaches the therapy system 100 may further include additional sources of solution or treatment compounds or substances, in addition to the solution source 114. For example, the therapy system 100 may include a first treatment source 160 and a second treatment source 162, both of which may be in fluid connection with the solution source 114. Locke teaches each of the first treatment source 160 and the second treatment source 162 may include one or more compounds that may be delivered to the tissue site for therapeutic purposes. Locke teaches in operation, as instillation fluid is being conducted from the solution source 114 to the dressing 102, additional therapeutic compounds from either or both of the first treatment source 160 and the second treatment source 162 may be added to the instillation fluid. Lock teaches additional treatment sources (not shown), may also be included in the therapy system 100, which may include additional treatment compounds for delivering to the tissue site (Locke para. 0056). As to the sequential delivery of fluids, Locke teaches the therapy system may be used in accordance with an operating method (Fig. 9) that senses various parameters to activate negative pressure or fluid therapy. Whether or not the measured parameters are in an acceptable range determines if the system adjusts fluid installation, and/or adjust additional treatment compounds (Locke Fig. 9; paras. 0093-0094). The therapy system of Locke essentially provides one or more therapeutic fluids in sequence in response to received data from the controller. Locke teaches it may be challenging for clinicians to recognize conditions, such as infection, at a tissue site undergoing negative pressure or fluid instillation therapy. Locke teaches by providing a therapy system that incorporates real-time diagnostic feedback with respect to parameters at a tissue site, clinicians may be better alerted to developing or changing conditions at the tissue site (Locke para. 0095) It would have been obvious to one having ordinary skill in the art before the invention was originally filed to provide the therapeutic fluid in sequence in response to conditions at the tissue site for the benefits taught in Locke.
Perry/Stiehl/Locke teach the fluids are delivered at specified flow rates (Perry paras. 0045-0046), pressures (Perry paras. 0045-0046), and temperatures (Perry para. 0058).
As to claim 14, Perry/Stiehl/Locke teach the HD comprises a nozzle configured and adapted to deliver one or more of the three distinct TFs at a measured rate to facilitate the removal of toxins and necrotic byproducts from the burn wound – where Stiehl teaches a generally wedge shaped nozzle which has an effective diameter that determines a generally flat spray pattern coinciding with a contour of the wound (Stiehl paras. 0029, 0034, 0032). Stiehl teaches the system for irrigation comprises a nozzle, a tube attached to the nozzle, and clear plastic tubular containment and collection bag having a fenestration (Stiehl Fig. 6). Lateral flow of effluent, from the spray pattern of the nozzle, is collected in the bag for disposal (Stiehl para. 0034-0035). Additionally, Locke teaches a wound cover 106 providing a seal adequate to maintain a negative pressure at a tissue site and vapor permeable, but impermeable to liquid (Locke Fig. 2; para. 0042).
Claims 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Perry US Patent Application Publication 2021/0228786 in view of Stiehl et al. WO 2019/094136 and further in view of Locke et al. US Patent Application Publication 2021/0060217 and further in view of “Fluid management in major burn injuries”, Mehmet Haberal et al., Baskent University (hereinafter referred to as Haberal).
As to claim 15, Perry/Stiehl/Locke teach the present invention substantially as claimed. Perry/Stiehl/Locke teach three distinct therapeutic fluids (TFs) delivered to a wound healing environment (Perry paras. 0045-0046 and 0058; Stiehl paras. 0029,0034,032; Locke paras. 0056 and 0093-0094). Perry/Stiehl/Locke do not specifically teach the claimed method where a first TF formulated to generate an optimal wound healing environment within 0 to 3 days after burning trauma; a second TF formulated to generate an optimal wound healing environment within 3 to 5 days after burning trauma; and a third TF formulated to generate an optimal wound healing environment within 6 to 9 days after burning trauma. Haberal et al., in the article “Fluid management in burn injuries” teaches various known procedures for fluid management in major burn injuries. Haberal teaches the methods include the Parkland formula, Modified Parkland formula, Brooke formula, Modified Brooke, Evans formula (1952), Monafo formula, Shriner’s Cincinnati, and Galveston formulas. Haberal teaches the most commonly used formulas are the Parkland, modified Parkland, Brook, modified Brooke, Evans and Monafo’s formulas and these formulas take into account the body weight and the burn surface area (S30, col. 2 through S31, col. 2). For most of the aforementioned formulas Haberal teaches in the initial 24 hours an Ringer’s lactated (RL) solution is delivered to the burn area, with a modified RL or colloid solution beginning the next 24 hours after burn trauma. Haberal does not specifically teach the claimed protocol. However, Haberal does teach the ideal burn resuscitation is one that effectively restores plasma volume, with no adverse effects. Isotonic crystalloids, hypertonic solutions and colloids have been used for this purpose. Haberal teaches the initial electrolyte measurements and potassium levels guide on the choice of fluid type, but RL solution is preferred through the initial post burn 24 hours (S31, col. 2). Haberal teaches in another example, Cohrane teaches using albumin for successful resuscitation in the early post burn period with decreased volume requirements and low weight gain compared to pure crystalloid resuscitation. Haberal teaches albumin administration is started at least 5 hours after the injury, and in the following days, the albumin support is continued until the blood level of albumin is 3 g/dl. Haberal teaches decisions for each individual patent are made according to current data from monitoring parameters such as existence of edema, urine output, central venous pressure, pulse rate, pulse oximetry, and so on (Haberal S32, columns 1 and 2). Haberal teaches all of the resuscitation formulas are meant to serve as guides only and fluid management in major burns should be monitored using clinical and laboratory parameters. Haberal teaches fluid shifts are rapid during the early period of burn shock (24-72 hours), so serial determinations of haematocrit, serum electrolytes, osmolality, calcium, glucose, and albumin are essential to help determine the appropriate method of fluid replacement. Therefore, based on the teachings of Haberal, it would have been obvious to one having ordinary skill in the art before the invention was originally filed to administer a first, second, and third therapeutic fluid in the claimed manner depending on the aforementioned factors associated with the state of the patient after the period of burn trauma.
As to claim 16, Perry/Stiehl/Locke/Haberal teach a combination of the first TF, the second TF, and the third TF is formulated to provide intense hydration conducive to wound healing, to restore normal osmotic pressure in the burned tissue, to chemically and hydrodynamically micro-debride and flush away necrotic byproducts and oxidizing compounds, to remove bacterial biofilm, to maintain a hygienic wound environment, and to inhibit one or more undesirable effects selected from the list consisting of inflammation, edema, and excessive fibrous tissue proliferation – where Perry/Stiehl/Locke/Haberal teach some of the same therapeutic fluids as the present invention – where Stiehl teaches it is notable that the only antiseptic currently with FDA clearance for debriding and cleansing wounds is an irrigation fluid containing sterile water and 0.05% chlorhexidine gluconate (CHG) (Stiehl para. 0004). Sterile water is present in the claimed invention as the first, second, and third TF. Since the therapeutic fluids of the combination of Perry/Stiehl/Locke/Haberal are the same as in the present invention, the TF of the references would obviously perform the same functions as the claimed compounds.
As to claim 17, Perry/Stiehl/Locke/Haberal teach the first TF is formulated to: remove coagulated and dead tissue from the burn wound, perform hydrodynamic micro-chemical debridement on the burn wound, increase tissue perfusion to remove pro-inflammatory soluble components within an interstitial fluid formed with an edema on the burn wound, mitigate bacterial biofilm formation on the burn wound, purify toxic substances from the burn wound, and reduce pain from the burn wound;
the second TF is formulated to: remove flaking from burnt skin layers on the burn wound, perform hydrodynamic micro-chemical debridement on the burn wound, restore isotonic condition in the burn wound, promote a topical anti-edematous and anti-inflammatory action on the burn wound, mitigate bacterial biofilm growth on the burn wound, and reduce pain from the burn wound; and
the third TF is formulated to: modulate the activation and conversion of resident skin fibroblasts into myofibroblasts in response to burn injury, promote a reduction of hypertrophic scars, keloids, and fibrosis on the burn wound, promote a more homogeneous wound healing without stains and roughness on the burn wound, promote a reduction of contractures and loss of fine motor movement on the burn wound, promote a topical anti-edematous and anti-inflammatory action on the burn wound, and mitigate bacterial biofilm growth on the burn wound – where Perry/Stiehl/Locke/Haberal teach some of the same therapeutic fluids as the present invention – where Stiehl teaches it is notable that the only antiseptic currently with FDA clearance for debriding and cleansing wounds is an irrigation fluid containing sterile water and 0.05% chlorhexidine gluconate (CHG) (Stiehl para. 0004). Sterile water is present in the claimed invention as the first, second, and third TF. Since the therapeutic fluids of the combination of Perry/Stiehl/Locke/Haberal are the same as in the present invention, the TF of the references would obviously perform the same functions as the claimed compounds.
As to claim 18, Perry/Stiehl/Locke/Haberal does not teach the claimed protocol. Haberal et al., in the article “Fluid management in burn injuries” teaches various known methods for fluid management in major burn injuries. Haberal teaches the methods include the Parkland formula, Modified Parkland formula, Brooke formula, Modified Brooke, Evans formula (1952), Monafo formula, Shriner’s Cincinnati, and Galveston formulas. Haberal teaches the most commonly used formulas are the Parkland, modified Parkland, Brook, modified Brooke, Evans and Monafo’s formulas and these formulas take into account the body weight and the burn surface area (S30, col. 2 through S31, col. 2). For most of the aforementioned formulas Haberal teaches in the initial 24 hours an Ringer’s lactated (RL) solution is delivered to the burn area, with a modified RL or colloid solution beginning the next 24 hours after burn trauma. However, Haberal does teach the ideal burn resuscitation is one that effectively restores plasma volume, with no adverse effects. Isotonic crystalloids, hypertonic solutions and colloids have been used for this purpose. Haberal teaches the initial electrolyte measurements and potassium levels guide on the choice of fluid type, but RL solution is preferred through the initial post burn 24 hours (S31, col. 2). Haberal teaches in another example, Cohrane teaches using albumin for successful resuscitation in the early post burn period with decreased volume requirements and low weight gain compared to pure crystalloid resuscitation. Haberal teaches albumin administration is started at least 5 hours after the injury, and in the following days, the albumin support is continued until the blood level of albumin is 3 g/dl. Again, Haberal teaches decisions for each individual patent are made according to current data from monitoring parameters such as existence of edema, urine output, central venous pressure, pulse rate, pulse oximetry, and so on (Haberal S32, columns 1 and 2). Haberal teaches all of the resuscitation formulas are meant to serve as guides only and fluid management in major burns should be monitored using clinical and laboratory parameters. Haberal teaches fluid shifts are rapid during the early period of burn shock (24-72 hours), so serial determinations of haematocrit, serum electrolytes, osmolality, calcium, glucose, and albumin are essential to help determine the appropriate method of fluid replacement. Therefore, based on the teachings of Haberal, it would have been obvious to one having ordinary skill in the art before the invention was originally filed to administer a first, second, and third therapeutic fluid in the claimed manner depending on the aforementioned factors associated with the state of the patient after the period of burn trauma.
As to claim 19, Perry/Stiehl/Locke/Haberal teach the burn wound treatment protocol comprises: administering the first TF in conjunction with venous hydration therapy for hydration to replace fluid and electrolyte losses, following recommendations of the American Burn Association, comprising:
Haberal teaches guidelines for common formulas used to initiate resuscitation estimate a crystalloid need for 2-4 (ml/kg body weight) divided by percent total body surface area (TBSA) burned during the first 24 hours (S34, col. 2); and
titrating fluid resuscitation to maintain a urine output of approximately 0.5-1.0 ml/kg/hour in an adult patient over 17 years of age or 1.0-1.5 ml/kg/hour in a pediatric patient 17 years of age or younger (S34, col. 2). While Haberal does not specifically teach 17 years of age as the threshold, Haberal does teach 0.5-1.0 ml/kg/hour in adults and 1.0-1.5 ml/kg/hour in children (S34, col. 2). It would have been obvious to one having ordinary skill in the art to provide one output for patients aged 17 years or younger and another output level for patients over 17 years of age, since 18 years of age is widely accepted as the age of an adult.
As to claim 20, As to claim 1, Perry teaches a system for treating a burn wound caused by a burning trauma (para. 0026), the system comprising: a Hydrodynamic Dressing (HD) – where Perry teaches that upon the application of a larger amount of pressure (such as from the pump or related irrigation fluid delivery source 121), this fluid could be expelled more as a stream, jet or other higher throughput (Perry para. 0035). Perry teaches the HD comprises a 130, sponge 150, packing 105, or gauze 107 (Figs. 2, 5; paras. 0029, 0034, 0050) configured and adapted to enclose the burn wound 10;
Perry teaches the system comprises distinct Therapeutic Fluids (TFs) – where Perry teaches 1) saline fluid for irrigation (paras. 0034, 0050), 2) anti-microbial solution of choice for a reduction in microorganisms (paras. 0034, 0064). Perry teaches when soaking the wound bed in fluid, improved wound moisture maintenance, irrigation debridement, physical disruption of biofilm, and removal of microorganisms may be achieved (Perry para. 0043). Perry teaches some fluids for irrigation and reduction of microorganisms as discussed above, but does not specifically teach three distinct fluids formulated to support a designated stage of healing with respect to the burn wound. Stiehl, from the same field of endeavor teaches a wound healing system involving wound debridement using a pulsatile flow of fluid to debride the wound and remove foreign biomass produced by bacteria (Stiehl para. 005). Stiehl teaches fluids used in the wound treatment include a chlorhexidine gluconate material that is used in irrigation using a continuous flow of irrigating fluid to the surface of the wound for debridement and removal of the detritus (para. 00113). It would have been obvious to one having ordinary skill in the art to use a therapeutic debriding agent taught in Stiehl in the wound healing system of Perry. Doing so would allow removal of necrotic tissue and microbial biofilms to create an optimal environment for healing and reduce the risk of infection.
Perry/Stiehl teach an Automated Fluid Delivery System (AFDS) configured and adapted to deliver each of the three TFs, respectively, to the burn wound enclosed within the HD at a respectively specified time (Perry para. 0043; Stiehl paras.005, 00113), temperature (Perry para. 0058), pressure (Perry paras. 0033, 0035; 0037), and flow rate (Perry para. 0033) according to a burn wound treatment protocol.
Perry/Stiehl teach the HD comprises a wound enclosure that isolates the wound from the nosocomial environment, facilitates wound observation, and facilitates hydrodynamic debridement – where Stiehl teaches a sterile bag that encloses the wound with a flexible tube and pump outside the sterile field with its nozzle inside the sterile field, where the solution is pressurized inside the tube to the preferred irrigation device and sprayed through its nozzle onto the wound site, thereby avoiding any direct contact of the solution outside the tube with the pump structures (Stiehl para. 0049). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to modify Perry with a sterile wound enclosure as taught in Stiehl so the wound is not contaminated in the irrigating process.
Perry/Stiehl teach the AFDS comprises an automated conditioning and pumping unit that is configured and adapted to deliver each of the three TFs, respectively (Perry para. 0051; Stiehl paras.005, 00113), to the burn wound enclosed within the HD. Perry/Stiehl do not specifically teach the three TF’s delivered in sequence. Locke teaches a therapy system for treating a tissue site with negative-pressure therapy and/or fluid instillation therapy in response to information received from a diagnostic unit (Locke, Abstract). Locke teaches the fluid therapy may comprise one or more sources of therapeutic compounds 114 (Locke Fig. 2) that may vary according to a prescribed therapy. Locke teaches examples of solutions that may be suitable for some prescriptions include hypochlorite-based solutions, silver nitrate (0.5%), sulfur-based solutions, biguanides, cationic solutions, and isotonic solutions (Locke para. 0047). Locke teaches the therapy system 100 may further include additional sources of solution or treatment compounds or substances, in addition to the solution source 114. For example, the therapy system 100 may include a first treatment source 160 and a second treatment source 162, both of which may be in fluid connection with the solution source 114. Locke teaches each of the first treatment source 160 and the second treatment source 162 may include one or more compounds that may be delivered to the tissue site for therapeutic purposes. Locke teaches in operation, as instillation fluid is being conducted from the solution source 114 to the dressing 102, additional therapeutic compounds from either or both of the first treatment source 160 and the second treatment source 162 may be added to the instillation fluid. Lock teaches additional treatment sources (not shown), may also be included in the therapy system 100, which may include additional treatment compounds for delivering to the tissue site (Locke para. 0056). As to the sequential delivery of fluids, Locke teaches the therapy system may be used in accordance with an operating method (Fig. 9) that senses various parameters to activate negative pressure or fluid therapy. Whether or not the measured parameters are in an acceptable range determines if the system adjusts fluid installation, and/or adjust additional treatment compounds (Locke Fig. 9; paras. 0093-0094). The therapy system of Locke essentially provides one or more therapeutic fluids in sequence in response to received data from the controller. Locke teaches it may be challenging for clinicians to recognize conditions, such as infection, at a tissue site undergoing negative pressure or fluid instillation therapy. Locke teaches by providing a therapy system that incorporates real-time diagnostic feedback with respect to parameters at a tissue site, clinicians may be better alerted to developing or changing conditions at the tissue site (Locke para. 0095) It would have been obvious to one having ordinary skill in the art before the invention was originally filed to provide the therapeutic fluid in sequence in response to conditions at the tissue site for the benefits taught in Locke.
Perry/Stiehl/Locke teach the fluids are delivered at specified flow rates (Perry paras. 0045-0046), pressures (Perry paras. 0045-0046), and temperatures (Perry para. 0058).
Perry/Stiehl/Locke teach the HD comprises a distributed array of nozzles 141 (Perry Figs. 7A, 7B para. 0053), each respective nozzle configured and adapted to deliver one or more of the three distinct TFs at a measured rate to facilitate the removal of toxins and necrotic byproducts from the burn wound (Perry Figs. 7A, 7B; paras. 0031, 0053).
Perry/Stiehl/Locke teach the HD comprises an outlet port 161,162, 164 (Perry Figs. 3A), configurable to route fluids that pass across the burn wound 10 enclosed within the HD to either a waste receptacle or a recirculating pump 122 (Perry Fig. 2; para. 0028). Perry also teaches the apertures 145 in the delivery conduit 141, 140 allow for the dripping, spraying, or seepage of solutions and related fluids into one or more wound beds 110 (Perry para. 0034), which allows a reduction in dwell time needed for the irrigation fluid to reach the wound bed and avoids the conventional approaches of having the fluid travel through a substantially or even full thickness of the sponge 150, packing 105, or gauze 107.
The limitations of the therapeutic fluids generating an optimal wound healing environment in a certain time period and the limitations directed to the advantages of the therapeutic fluids are specifically directed to the function of the therapeutic fluids. The structure and materials used in the combination of Perry, Stiehl, and Locke are the same as the therapeutic fluids of the present invention and used in a hydrodynamic wound therapy system as described in the rejections of claims 1-3 above. 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. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997). “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) (emphasis in original). In this case, since Perry/Stiehl/Locke comprise therapeutic fluids for use in wound healing and are capable of functioning in the manner as recited in claims 7-9. Since structural limitations are met by the references, it may be reasonably concluded that any function that will occur will be inherent which satisfies a prima facie case of obviousness. “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). MPEP 2112.01(I.)
The limitations of a burn wound treatment protocol are directed to a function of the system rather than the structure of the claimed system. The structure of the wound treatment systems – i.e. nozzle, waste container, pressurized fluids, and materials used in the combination of Perry, Stiehl, and Locke are the same as the therapeutic fluids of the present invention and used in a hydrodynamic wound therapy system as described in the rejections of claims 1-3 above. 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. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997). “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) (emphasis in original). In this case, since Perry/Stiehl/Locke comprise a wound treatment system using therapeutic fluids for use in wound healing and are capable of functioning in the manner as recited in claims 10 and 11. Since structural limitations are met by the references, it may be reasonably concluded that any function that will occur will be inherent which satisfies a prima facie case of obviousness. “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). MPEP 2112.01(I.)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bangera et al. WO 2018/005449 is cited to show automated debridement systems. Locke et al. US 2021/0196871 and Blott et al. US 2016/0354535 are cited to show a method of delivering fluid to a wound therapy dressing.
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/JACQUELINE F STEPHENS/ Primary Examiner, Art Unit 3781
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