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 – 20 are examined here-in.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code in lines 2-3 and 6-7 on page 7. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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.
Claims 4, 9, 11, 16, and 18 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
The term “low” in claims 4, 11, and 18 is a relative term which renders the claim indefinite. The term “low” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 9 recites the limitation "phenolsulfonic acid". There is insufficient antecedent basis for this limitation in the claim because claim 9 depends on independent claim 8 which does not recite the inclusion of phenolsulfonic acid.
Claim 16 recites the limitation "phenolsulfonic acid". There is insufficient antecedent basis for this limitation in the claim because claim 16 depends on independent claim 15 which does not recite the inclusion of phenolsulfonic acid.
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.
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 non-obviousness.
Claims 1 – 3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Basara (US 2016/0058718 A1) in view of Bennison (Bennison, L.R. et al. “The pH of wounds during healing and infection: a descriptive literature review” Medtronic 2017, 25(2), pages 63 - 69).
Basara teaches a method for treating a chronic wound or bacterial infection that includes mechanically debriding a wound and applying a formulation that includes phenolsulfonic acid and guaiacolsulfonic acid (abstract).
Basara teaches wounds are characterized by necrotic tissue which delays healing, is a reservoir for bacterial growth, and contains inflammatory compounds that promotes inflammation and impairs cellular migration (paragraph 0003).
Basara teaches a liquid or gel formulation for treating wounds which has phenolsulfonic acid and guaiacolsulfonic acid (paragraphs 0009 – 0019), as well as an alternative formulation which has phenolsulfonic acid and benzenesulfonic acid (paragraphs 0020 – 0028).
Basara teaches that the liquid and gel formulations reduce the size of the wound or heal the wound when applied, by debriding and washing away necrotic tissue (paragraph 0136). Basara teaches that removal of necrotic tissue prevents the body from a destructive inflammatory immune response (paragraph 0161).
Basara teaches the formulation can be applied as a single application or can be applied multiple times until the wound is healed (paragraphs 0201 – 0202).
Basara does not teach normalizing or adjusting the pH of tissue.
Bennison teaches that wound pH is conducive to bacterial proliferation and has the potential to manage wound healing (abstract, page 63 column 2).
Bennison teaches that human skin has a natural pH of 4.2 – 5.6, which is an acidic range that provides an antimicrobial defense, discouraging the growth of bacteria (page 65 column 1). Bennison teaches that chronic wounds have a pH range of 7.2 to 8.9, which is alkaline and contributes to the proliferation of bacteria (page 65 column 2). Bennison teaches that wound pH can predict the progression of healing and be indicative of biochemical processes of healing (page 65 column 2). Bennison teaches that when the wound has an acidic pH there is proliferation of fibroblasts, DNA cell synthesis, oxygenation, collagen formation, angiogenesis, and macrophage activity (page 66 column 1). Further, Bennison teaches that wound pH that is acidic is associated with more rapid wound healing (page 66 column 1).
Bennison teaches that alkaline pH is associated with impaired healing and immune response, increased bacterial growth, and decreased oxygen supply (page 66 column 1).
Bennison teaches that “modulating pH to a more acidic environment has been observed to increase the rate of wound healing” (page 66 column 1).
The combination of Basara and Bennison’s teachings renders claims 1 – 3 and 7 prima facie obvious according to MPEP 2143(i)(g) because a person of ordinary skill in the art would be motivated to modify Basara’s method to include a pH adjustment step as taught by Bennison because Bennison teaches that modulating pH to be more acidic results in more rapid wound healing (page 66 column 1). This combination of prior art references is prima facie obvious according to MPEP 2143(i)(g) because Bennison’s teachings would motivate a person of ordinary skill in the art to modify the method of Basara to arrive at the claimed invention.
The combination of Basara’s teaching for a method for treating a wound or bacterial infection by applying a formulation that includes phenolsulfonic acid and guaiacolsulfonic acid or benzenesulfonic acid one or more times (abstract, paragraphs 0003, 0009 – 0028, 0201 – 0202) with Bennison’s guidance to target an acidic pH in order to increase the rate of wound healing (page 66 column 1) reads on instant claim 1. A person of ordinary skill in the art would be motivated to modify Basara’s method with Bennison’s teaching to control the wound pH and make it acidic because Bennison teaches that an acidic wound pH is associated with more rapid healing (page 66 column 1). An acidic pH reads on the instant limitation of “normalizing the pH” because the instant specification states a normalized pH ranges from 4 to 6.2, which is acidic (instant specification page 6 lines 18 – 19).
Basara teaches an embodiment where the formulation is applied to a chronic wound once every seven days until the wound is healed (paragraph 0202, Figures 1 – 4), reading on instant claim 2.
Basara’s teaching for mechanically debriding a wound, removing the necrotic tissue, and applying a formulation that includes phenolsulfonic acid and guaiacolsulfonic acid (abstract, paragraphs 0004, 0135 – 0136, 0200, 0202 - 0203) reads on instant claim 3. Basara teaches mechanical debridement with surgical implements, and also teaches mechanical and chemical debridement resulting from application of the formulation, noting that debriding the wound destroys biofilm and bacteria (paragraphs 0135 – 0136). Removal of necrotic tissue reads on “sloughing”, and Basara’s teaching that biofilm and additional bacteria are removed reads on planktonic bacteria.
Basara’s teaching that the formulation is a gel (paragraphs 0009 – 0028) reads on instant claim 7.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Basara (as cited above) in view of Bennison (as cited above) and further in view of Babaev (US 6,960,173).
Basara and Bennison’s teachings are discussed above.
The combination of Basara and Bennison does not teach exposing the debrided tissue to low frequency ultrasound.
Babaev teaches the missing element of the combination of Basara and Bennison.
Babaev teaches a method for treating a wound using ultrasound (abstract, column 2 lines 56 – 58). Babaev teaches that ultrasound waves delivered to a wound surface function to increase blood flow, kill bacteria, and stimulate healthy tissue cells (column 2 lines 34 – 39). Babaev teaches that the use of ultrasound waves may enable the treatment of wounds without antibiotics (column 2 lines 53 – 55).
The combination of Basara, Bennison, and Babaev’s teachings renders claim 4 prima facie obvious according to MPEP 2143(i)(g) because a person of ordinary skill in the art would be motivated to modify Basara’s method to include a pH adjustment step as taught by Bennison because Bennison teaches that modulating pH to be more acidic results in more rapid wound healing (page 66 column 1). A person of ordinary skill in the art would be further motivated to use ultrasound because Babaev teaches that the use of ultrasound waves promotes wound healing and may enable the treatment of wounds without antibiotics (column 2 lines 34 – 39, 53 – 55) which would be advantageous to limit antibiotic exposure and acquired resistance in bacteria. This combination of prior art references is prima facie obvious according to MPEP 2143(i)(g) because Bennison’s teachings would motivate a person of ordinary skill in the art to modify the method of Basara, then Babaev’s teachings would motivate a person of ordinary skill in the art to modify the method of Basara and Bennison to include ultrasound, in order to promote wound healing, thus arriving at the claimed invention.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Basara (as cited above) in view of Bennison (as cited above) and further in view of Minatel (Minatel, D.G. et al. “Phototherapy promotes healing of chronic diabetic leg ulcers that failed to respond to other therapies” Lasers in Surgery and Medicine 2009, 41: 433 – 441).
Basara and Bennison’s teachings are discussed above.
The combination of Basara and Bennison does not teach exposing the debrided tissue to laser energy.
Minatel teaches the missing element of the combination of Basara and Bennison.
Minatel teaches that phototherapy with 660 and 890 nm light promotes wound healing (abstract). Minatel teaches that treatment with lasers has been reported to result in complete healing of diabetic ulcers that were not responsive to other treatments(page 438 column 1). Notably, Minatel teaches that wound debridement must be done carefully in order for treatment with laser energy to show wound healing benefits (page 438 column 2).
Minatel teaches ulcer healing and granulation is higher with phototherapy treatment (p. 436 column 1, Table 3, Figure 2) and although the exact mechanisms are not know, treatment with light promotes fibroblast proliferation, collagen synthesis, ATP synthesis, and blood vessel formation (page 438 column 1).
The combination of Basara, Bennison, and Minatel’s teachings renders claim 5 prima facie obvious according to MPEP 2143(i)(g) because a person of ordinary skill in the art would be motivated to modify Basara’s method to include a pH adjustment step as taught by Bennison because Bennison teaches that modulating pH to be more acidic results in more rapid wound healing (page 66 column 1). A person of ordinary skill in the art would be further motivated to use laser therapy because Minatel teaches that treatment with light promotes fibroblast proliferation, collagen synthesis, ATP synthesis, and blood vessel formation (page 438 column 1) and teaches that light therapy leads to healing in diabetic ulcers that were not responsive to other treatments (page 438 column 1). This combination of prior art references is prima facie obvious according to MPEP 2143(i)(g) because Bennison’s teachings would motivate a person of ordinary skill in the art to modify the method of Basara, then Minatel’s teachings would motivate a person of ordinary skill in the art to modify the method of Basara and Bennison to include laser treatment, in order to promote wound healing, thus arriving at the claimed invention.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Basara (as cited above) in view of Bennison (as cited above) and further in view of Miller (US 4,846,181).
Basara and Bennison’s teachings are discussed above.
The combination of Basara and Bennison does not teach exposing the debrided tissue to electrostimulation.
Miller teaches the missing element of the combination of Basara and Bennison.
Miller teaches electrical stimulation for wound healing (abstract).
Miller teaches that electrical stimulation can be done once the wound has been debrided and cleansed, or electrical stimulation can be used to debride the wound (column 25 lines 15 – 27). Miller teaches that electrical stimulation artificially increases the inflammation process, bringing blood, nutrients, hormones, platelets, and white blood cells to the wound site to aid in the repair process (column 25 lines 44 – 58). Miller teaches that wound surface area decreases significantly with electrical stimulation (with a 75% reduction in wound surface area over 3 weeks) compared to wounds not treated with electrical stimulation (with 32% reduction in wound surface area over 3 weeks) (column 10, Table 3).
The combination of Basara, Bennison, and Minatel’s teachings renders claim 6 prima facie obvious according to MPEP 2143(i)(g) because a person of ordinary skill in the art would be motivated to modify Basara’s method to include a pH adjustment step as taught by Bennison because Bennison teaches that modulating pH to be more acidic results in more rapid wound healing (page 66 column 1). A person of ordinary skill in the art would be further motivated to use electrostimulation because Miller teaches that electrostimulation promotes wound healing and shows nearly 50% greater healing over a 3 week period (abstract, column 10, Table 3, column 25). This combination of prior art references is prima facie obvious according to MPEP 2143(i)(g) because Bennison’s teachings would motivate a person of ordinary skill in the art to modify the method of Basara, then Miller’s teachings would motivate a person of ordinary skill in the art to modify the method of Basara and Bennison to include electrostimulation in order to promote wound healing, thus arriving at the claimed invention.
Claims 8 – 10 and 14 – 17 are rejected under 35 U.S.C. 103 as being unpatentable over Basara (as cited above) in view of Bennison (as cited above) and further in view of Reddell (US 2016/0068499 A1).
Basara and Bennison’s teachings are discussed above.
Notably, Basara teaches the formulation may include sulfonic acid (free sulfuric acid) (paragraph 0164).
The combination of Basara and Bennison does not teach the method of promoting healing in tissue is tissue of a surgical site or tissue of an acute injury.
Reddell teaches the missing elements of the combination of Basara and Bennison.
Reddell teaches methods of promoting wound healing (abstract).
Reddell teaches that wounds may include surgical incisions, acute wounds such as from a burn, or chronic wounds (paragraphs 0032 - 0033). Reddell suggests that surgical incisions, acute wounds, and chronic wounds can all be treated similarly (paragraphs 0032 – 0034, 0040 – 0041).
The combination of Basara, Bennison, and Reddell’s teachings renders claims 8 – 10 and 14 – 17 prima facie obvious according to MPEP 2143(i)(g) because a person of ordinary skill in the art would be motivated to modify Basara’s method to include a pH adjustment step as taught by Bennison because Bennison teaches that modulating pH to be more acidic results in more rapid wound healing (page 66 column 1). A person of ordinary skill in the art would be further motivated to use the combination of Basara’s and Bennison’s teachings for surgical sites and acute wounds because Reddell suggests that these types of wounds can be treated in a similar manner to chronic wounds (paragraphs 0032 – 0034, 0040 – 0041). This combination of prior art references is prima facie obvious according to MPEP 2143(i)(g) because Bennison’s teachings would motivate a person of ordinary skill in the art to modify the method of Basara to normalize the pH of the wound, then Reddell’s suggestion that surgical wounds, acute wounds, and chronic wounds can all be approached with a similar treatment method would motivate a person of ordinary skill in the art to implement the combination of Bennison and Basara for each of these wound types, thus arriving at the claimed invention.
The combination of Basara’s teaching for a method for treating a wound or bacterial infection by applying a formulation that includes free sulfuric acid and guaiacolsulfonic acid or benzenesulfonic acid one or more times (abstract, paragraphs 0003, 0009 – 0028, 0164, 0201 – 0202) with Bennison’s guidance to target an acidic pH in order to increase the rate of wound healing (page 66 column 1), and further with Reddell’s teaching that surgical wounds can be treated with the same methods as chronic wounds reads on instant claim 8. A person of ordinary skill in the art would be motivated to modify Basara’s method with Bennison’s teaching to control the wound pH and make it acidic because Bennison teaches that an acidic wound pH is associated with more rapid healing (page 66 column 1). An acidic pH reads on the instant limitation of “normalizing the pH” because the instant specification states a normalized pH ranges from 4 to 6.2, which is acidic (instant specification page 6 lines 18 – 19).
Basara teaches an embodiment where a formulation of phenolsulfonic acid and guaiacolsulfonic acid is applied to a chronic wound once every seven days until the wound is healed (Table 2, paragraph 0202, Figures 1 – 4), reading on instant claim 9. As discussed above, a person of ordinary skill in the art would be motivated to implement the combined teachings of Basara and Bennison to promote healing of tissue of a surgical site because Reddell suggests that surgical wounds can be treated with the same methods as chronic wounds (paragraphs 0032 – 0034, 0040 – 0041).
Basara’s teaching for mechanically debriding a wound, removing the necrotic tissue, and applying a formulation that includes free sulfuric acid and guaiacolsulfonic acid (abstract, paragraphs 0004, 0135 – 0136, 0164, 0200, 0202 - 0203) reads on instant claim 10. Basara teaches mechanical debridement with surgical implements, and also teaches mechanical and chemical debridement resulting from application of the formulation, noting that debriding the wound destroys biofilm and bacteria (paragraphs 0135 – 0136). Removal of necrotic tissue reads on “sloughing”, and Basara’s teaching that biofilm and additional bacteria are removed reads on planktonic bacteria.
Basara’s teaching that the formulation is a gel (paragraphs 0009 – 0028) reads on instant claim 14.
The combination of Basara’s teaching for a method for treating a wound or bacterial infection by applying a formulation that includes free sulfuric acid and guaiacolsulfonic acid or benzenesulfonic acid one or more times (abstract, paragraphs 0003, 0009 – 0028, 0164, 0201 – 0202) with Bennison’s guidance to target an acidic pH in order to increase the rate of wound healing (page 66 column 1), and further with Reddell’s teaching that acute wounds can be treated with the same methods as chronic wounds reads on instant claim 15. A person of ordinary skill in the art would be motivated to modify Basara’s method with Bennison’s teaching to control the wound pH and make it acidic because Bennison teaches that an acidic wound pH is associated with more rapid healing (page 66 column 1). An acidic pH reads on the instant limitation of “normalizing the pH” because the instant specification states a normalized pH ranges from 4 to 6.2, which is acidic (instant specification page 6 lines 18 – 19).
Basara teaches an embodiment where a formulation of phenolsulfonic acid and guaiacolsulfonic acid is applied to a chronic wound once every seven days until the wound is healed (Table 2, paragraph 0202, Figures 1 – 4), reading on instant claim 16. As discussed above, a person of ordinary skill in the art would be motivated to implement the combined teachings of Basara and Bennison to promote healing of tissue of an acute wound because Reddell suggests that surgical wounds can be treated with the same methods as chronic wounds (paragraphs 0032 – 0034, 0040 – 0041).
Basara’s teaching for mechanically debriding a wound, removing the necrotic tissue, and applying a formulation that includes free sulfuric acid and guaiacolsulfonic acid (abstract, paragraphs 0004, 0135 – 0136, 0200, 0164, 0202 - 0203) reads on instant claim 17. Basara teaches mechanical debridement with surgical implements, and also teaches mechanical and chemical debridement resulting from application of the formulation, noting that debriding the wound destroys biofilm and bacteria (paragraphs 0135 – 0136). Removal of necrotic tissue reads on “sloughing”, and Basara’s teaching that biofilm and additional bacteria are removed reads on planktonic bacteria.
Claims 11 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Basara (as cited above) in view of Bennison (as cited above) further in view of Reddell (as cited above), and further in view of Babaev (as cited above).
Basara, Bennison, and Reddell’s teachings are discussed above.
The combination of Basara, Bennison, and Reddell does not teach exposing the debrided tissue to low frequency ultrasound.
Babaev teaches the missing element of the combination of Basara, Bennison, and Reddell.
Babaev teaches a method for treating a wound using ultrasound (abstract, column 2 lines 56 – 58). Babaev teaches that ultrasound waves delivered to a wound surface function to increase blood flow, kill bacteria, and stimulate healthy tissue cells (column 2 lines 34 – 39). Babaev teaches that the use of ultrasound waves may enable the treatment of wounds without antibiotics (column 2 lines 53 – 55).
The combination of Basara, Bennison, Reddell, and Babaev’s teachings render claims 11 and 18 prima facie obvious according to MPEP 2143(i)(g) because a person of ordinary skill in the art would be motivated to modify Basara’s method to include a pH adjustment step as taught by Bennison because Bennison teaches that modulating pH to be more acidic results in more rapid wound healing (page 66 column 1). As discussed above, person of ordinary skill in the art would be further motivated to use the combination of Basara’s and Bennison’s teachings for surgical sites and acute wounds because Reddell suggests that these types of wounds can be treated in a similar manner to chronic wounds (paragraphs 0032 – 0034, 0040 – 0041). Then, a person of ordinary skill in the art would be further motivated to include ultrasound therapy because Babaev teaches that the use of ultrasound waves promotes wound healing and may enable the treatment of wounds without antibiotics (column 2 lines 34 – 39, 53 – 55) which would be advantageous to limit antibiotic exposure and acquired resistance in bacteria. This combination of prior art references is prima facie obvious according to MPEP 2143(i)(g) because Bennison’s teachings would motivate a person of ordinary skill in the art to modify the method of Basara, Reddell’s teachings would motivated a person of skill in the art to apply the combination of Basara and Bennison to surgical and acute wounds, then Babaev’s teachings would motivate a person of ordinary skill in the art to include ultrasound (modifying the combination of Basara, Bennison, and Reddell), in order to promote wound healing, thus arriving at the claimed invention.
Claims 12 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Basara (as cited above) in view of Bennison (as cited above) further in view of Reddell (as cited above), and further in view of Minatel (as cited above).
Basara, Bennison, and Reddell’s teachings are discussed above.
The combination of Basara, Bennison, and Reddell does not teach exposing the debrided tissue to laser energy.
Minatel teaches the missing element of the combination of Basara, Bennison, and Reddell.
Minatel teaches that phototherapy with 660 and 890 nm light promotes wound healing (abstract). Minatel teaches that treatment with lasers has been reported to result in complete healing of diabetic ulcers that were not responsive to other treatments(page 438 column 1). Notably, Minatel teaches that wound debridement must be done carefully in order for treatment with laser energy to show wound healing benefits (page 438 column 2).
Minatel teaches ulcer healing and granulation is higher with phototherapy treatment (p. 436 column 1, Table 3, Figure 2) and although the exact mechanisms are not know, treatment with light promotes fibroblast proliferation, collagen synthesis, ATP synthesis, and blood vessel formation (page 438 column 1).
The combination of Basara, Bennison, Reddell, and Minatel’s teachings render claims 12 and 19 prima facie obvious according to MPEP 2143(i)(g) because a person of ordinary skill in the art would be motivated to modify Basara’s method to include a pH adjustment step as taught by Bennison because Bennison teaches that modulating pH to be more acidic results in more rapid wound healing (page 66 column 1). As discussed above, person of ordinary skill in the art would be further motivated to use the combination of Basara’s and Bennison’s teachings for surgical sites and acute wounds because Reddell suggests that these types of wounds can be treated in a similar manner to chronic wounds (paragraphs 0032 – 0034, 0040 – 0041). Then, a person of ordinary skill in the art would be further motivated to use laser therapy because Minatel teaches that treatment with light promotes fibroblast proliferation, collagen synthesis, ATP synthesis, and blood vessel formation (page 438 column 1) and teaches that light therapy leads to healing in diabetic ulcers that were not responsive to other treatments (page 438 column 1). This combination of prior art references is prima facie obvious according to MPEP 2143(i)(g) because Bennison’s teachings would motivate a person of ordinary skill in the art to modify the method of Basara, Reddell’s teachings would motivated a person of skill in the art to apply the combination of Basara and Bennison to surgical and acute wounds, then Minatel’s teachings would motivate a person of ordinary skill in the art to include laser energy (modifying the combination of Basara, Bennison, and Reddell), in order to promote wound healing, thus arriving at the claimed invention.
Claims 13 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Basara (as cited above) in view of Bennison (as cited above) further in view of Reddell (as cited above), and further in view of Miller (as cited above).
Basara, Bennison, and Reddell’s teachings are discussed above.
The combination of Basara, Bennison, and Reddell does not teach exposing the debrided tissue to electrostimulation.
Miller teaches the missing element of the combination of Basara, Bennison, and Reddell.
Miller teaches electrical stimulation for wound healing (abstract).
Miller teaches that electrical stimulation can be done once the wound has been debrided and cleansed, or electrical stimulation can be used to debride the wound (column 25 lines 15 – 27). Miller teaches that electrical stimulation artificially increases the inflammation process, bringing blood, nutrients, hormones, platelets, and white blood cells to the wound site to aid in the repair process (column 25 lines 44 – 58). Miller teaches that wound surface area decreases significantly with electrical stimulation (with a 75% reduction in wound surface area over 3 weeks) compared to wounds not treated with electrical stimulation (with 32% reduction in wound surface area over 3 weeks) (column 10, Table 3).
The combination of Basara, Bennison, Reddell, and Miller’s teachings render claims 13 and 20 prima facie obvious according to MPEP 2143(i)(g) because a person of ordinary skill in the art would be motivated to modify Basara’s method to include a pH adjustment step as taught by Bennison because Bennison teaches that modulating pH to be more acidic results in more rapid wound healing (page 66 column 1). As discussed above, person of ordinary skill in the art would be further motivated to use the combination of Basara’s and Bennison’s teachings for surgical sites and acute wounds because Reddell suggests that these types of wounds can be treated in a similar manner to chronic wounds (paragraphs 0032 – 0034, 0040 – 0041). Then, a person of ordinary skill in the art would be further motivated to use electrostimulation because Miller teaches that electrostimulation promotes wound healing and shows nearly 50% greater healing over a 3 week period (abstract, column 10, Table 3, column 25).This combination of prior art references is prima facie obvious according to MPEP 2143(i)(g) because Bennison’s teachings would motivate a person of ordinary skill in the art to modify the method of Basara, Reddell’s teachings would motivated a person of skill in the art to apply the combination of Basara and Bennison to surgical and acute wounds, then Miller’s teachings would motivate a person of ordinary skill in the art to include electrostimulation (modifying the combination of Basara, Bennison, and Reddell), in order to promote wound healing, thus arriving at the claimed invention.
Conclusion
All claims are rejected. No claims are allowed.
Correspondence
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/TORIANA N. VIGIL/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612