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 .
Response to Arguments
Applicant’s arguments, see Remarks, filed 03/23/2026, with respect to the rejection(s) of claim(s) 39 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made under 35 U.S.C. 103 as being unpatentable over Yarmush (US 20180250427 A1) in view of Goldberg (US 20160213922 A1), and Ivanova (US 20170312345 A1).
Yarmush teaches method comprising applying a pulsed electric field comprising an electric field strength from 0.1 kV/cm to 9.9 kV/cm ([abstract] To eradicate at least a portion of a biofilm on a medical implant, for example, 1500 volts can be applied through an electrode system) ([0010] The critical electric field strength (Ecr) needed to eradicate 100-80% of bacteria in such a treated area is expected to be between about 100 and 150 V/mm when 300 pulses are applied, and between about 225 and 250 V/mm when 150 pulses are applied) to a surface of the tissue comprising the bacterial biofilm until the bacterial biofilm is inactivated ([0021] Referring to FIG. 1, an exemplary disinfection system 100 may include a controller 105 having a pulse generator 110 for generation of pulsed electric fields (PEF) to be applied to biofilm infections). Therefore, the range of electric field strength from 0.1 kV/cm to 9.9 kV/cm is taught by Yarmush ([0010] range of 1.0 to 1.5 kV/cm and 2.25 to 3.0 kV/cm when pulsed are applied) to accomplish the deactivating of the bacterial biofilm.
Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include the method comprising applying a pulsed electric field comprising an electric field strength from 0.1 kV/cm to 9.9 kV/cm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Furthermore, Goldberg teaches disrupting a bacterial biofilm on a tissue comprising applying a sub-microsecond pulsed electric field ([0045] FIG. 24 is a graphical illustration indicating bacterial load reduction by use of pulsed electric fields) sub-microsecond pulsed electric fields ([0047] Typical ranges of numerical values describing the electric field pulses may include 100 nanoseconds to 100 millisecond for the pulse durations) ([0140] In this manner, pulsed electric fields may not only increase drug penetration into bacteria cells, but may also induce increased drug diffusion in biofilms). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include the method comprising applying a sub-microsecond pulsed electric field, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
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.
Claim(s) 39-42, 44, 48-51, 53-56, and 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yarmush (US 20180250427 A1) in view of Goldberg (US 20160213922 A1), and Ivanova (US 20170312345 A1).
Regarding claim 39, Yarmush teaches a method of inactivating a bacterial biofilm on a tissue ([0009] With sufficient electric field strength, biofilm disruption and microbial eradication can be achieved without damage to the medical device on which the microbes and biofilm are found), the method comprising applying a sub-microsecond pulsed electric field comprising an electric field strength from 0.1 kV/cm to 9.9 kV/cm ([abstract] To eradicate at least a portion of a biofilm on a medical implant, for example, 1500 volts can be applied through an electrode system) ([0010] The critical electric field strength (Ecr) needed to eradicate 100-80% of bacteria in such a treated area is expected to be between about 100 and 150 V/mm when 300 pulses are applied, and between about 225 and 250 V/mm when 150 pulses are applied) to a surface of the tissue comprising the bacterial biofilm until the bacterial biofilm is inactivated ([0021] Referring to FIG. 1, an exemplary disinfection system 100 may include a controller 105 having a pulse generator 110 for generation of pulsed electric fields (PEF) to be applied to biofilm infections). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Yarmush to use a pulsed electric field comprising an electric field strength from 0.1 kV/cm to 9.9 kV/cm. Doing so allows for an effective electric field strength to deactivate the bacterial biofilms.
Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include the method comprising applying a pulsed electric field comprising an electric field strength from 0.1 kV/cm to 9.9 kV/cm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Yarmush fails to teach a treatment of applying a sub-microsecond pulsed electric field; while limiting inactivation of planktonic bacteria in proximity to the bacterial biofilm and damage to the tissue.
However, Ivanova teaches while limiting inactivation of planktonic bacteria ([0291] Biofilm cell growth (by colony counting as CFU/mL) was significantly reduced (p<0.05 compared to Control) in biofilms formed by S. aureus ATCC25923 (lab reference strain) and S. aureus Oxford (clinical isolate). No effect on planktonic cell growth was recorded). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Yarmush to include while limiting inactivation of planktonic bacteria. Doing so limits the harm to the surrounding tissue while targeting the biofilm.
Further, Goldberg teaches disrupting a bacterial biofilm on a tissue ([0045] FIG. 24 is a graphical illustration indicating bacterial load reduction by use of pulsed electric fields), comprising applying a sub-microsecond pulsed electric field ([0047] Typical ranges of numerical values describing the electric field pulses may include 100 nanoseconds to 100 millisecond for the pulse durations) ([0140] In this manner, pulsed electric fields may not only increase drug penetration into bacteria cells, but may also induce increased drug diffusion in biofilms); in proximity to the bacterial biofilm and damage to the tissue ([0137] Using controlled pulse strength, duration, frequency, and temporal delivery, systems and methods of the present invention may provide for enhanced outcomes compared to other non-specific, chemical, surgical and ablative approaches, by allowing for selective targeting of specific cell types, agents or bacteria, as well as allow for extended control of cell, agent or bacteria density without significant effect of tissue matrix or tissue mechanical properties). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Yarmush to include disrupting a bacterial biofilm on a tissue comprising applying a sub-microsecond pulsed electric field; in proximity to the bacterial biofilm and damage to the tissue. Doing so limits the harm to the surrounding tissue while targeting the biofilm.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include the method comprising applying a sub-microsecond pulsed electric field, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 40, Yarmush teaches the method of claim 39, wherein the sub-microsecond pulsed electric field comprises from 5 pulses to 1000 pulses ([0035] To quantify the effect of pulse number using 100, 150, and 300 pulses). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein the sub-microsecond pulsed electric field comprises from 5 pulses to 1000 pulses, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 41, Yarmush teaches the method of claim 39, wherein the sub-microsecond pulsed electric field comprises an electric field strength from 0.1 kV/cm to 5.0 kV/cm ([abstract] To eradicate at least a portion of a biofilm on a medical implant, for example, 1500 volts can be applied through an electrode system) ([0010] The critical electric field strength (Ecr) needed to eradicate 100-80% of bacteria in such a treated area is expected to be between about 100 and 150 V/mm when 300 pulses are applied, and between about 225 and 250 V/mm when 150 pulses are applied). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Yarmush to include wherein the sub-microsecond pulsed electric field comprises an electric field strength from 0.1 kV/cm to 5.0 kV/cm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 42, Yarmush teaches the method of claim 39, wherein the sub-microsecond pulsed electric field comprises an electric field strength from about 0.5 kV/cm to about 3.5 kV/cm ([abstract] To eradicate at least a portion of a biofilm on a medical implant, for example, 1500 volts can be applied through an electrode system) ([0010] The critical electric field strength (Ecr) needed to eradicate 100-80% of bacteria in such a treated area is expected to be between about 100 and 150 V/mm when 300 pulses are applied, and between about 225 and 250 V/mm when 150 pulses are applied). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Yarmush to include wherein the sub-microsecond pulsed electric field comprises an electric field strength from about 0.5 kV/cm to about 3.5 kV/cm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 44, Yarmush teaches the method of claim 39, wherein the sub-microsecond pulsed electric field has a frequency from 0.5 Hz to 3 MHz ([0010] a pulse delivery frequency of 2 Hz). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein the sub-microsecond pulsed electric field has a frequency from 0.5 Hz to 3 MHz, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 48, Yarmush teaches the method of claim 39, but fails to teach wherein the method is for treating acne. However, Goldberg teaches wherein the method is for treating acne ([0009] In addition to efforts for improving wound care, the desire for a rejuvenated appearance has led to over 2.1 million skin rejuvenation procedures and accounted for 1.8 billion in spending in the US alone (2012) in the treatment of scars, striae, age-related rhytids, photodamage, acne, and trauma). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Yarmush to include wherein the method is for treating acne. Doing so targets acne forming bacteria for treatment.
Regarding claim 49, Yarmush teaches the method of claim 48, but fails to teach wherein applying the sub-microsecond pulsed electric field comprises treating acne in a region of skin of a subject, by applying the sub-microsecond pulsed electric field to the region of skin comprising a C. acnes bacterial biofilm, wherein the sub-microsecond pulsed electric field is applied at an electric field strength sufficient to inactivate the C. acnes bacterial biofilm while limiting inactivation of co- habiting commensal bacteria and damage to surrounding tissues in a region of skin.
However, Goldberg teaches method of claim 48, wherein applying the sub-microsecond pulsed electric field comprises treating acne in a region of skin of a subject ([0009] In addition to efforts for improving wound care, the desire for a rejuvenated appearance has led to over 2.1 million skin rejuvenation procedures and accounted for 1.8 billion in spending in the US alone (2012) in the treatment of scars, striae, age-related rhytids, photodamage, acne, and trauma), by applying the sub-microsecond pulsed electric field to the region of skin comprising a C. acnes bacterial biofilm ([0137] Using controlled pulse strength, duration, frequency, and temporal delivery, systems and methods of the present invention may provide for enhanced outcomes compared to other non-specific, chemical, surgical and ablative approaches, by allowing for selective targeting of specific cell types, agents or bacteria, as well as allow for extended control of cell, agent or bacteria density without significant effect of tissue matrix or tissue mechanical properties), wherein the sub-microsecond pulsed electric field is applied at an electric field strength sufficient to inactivate the C. acnes bacterial biofilm while limiting inactivation of co- habiting commensal bacteria and damage to surrounding tissues in a region of skin ([0137]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Yarmush to include wherein applying the sub-microsecond pulsed electric field comprises treating acne in a region of skin of a subject, by applying the sub-microsecond pulsed electric field to the region of skin comprising a C. acnes bacterial biofilm, wherein the sub-microsecond pulsed electric field is applied at an electric field strength sufficient to inactivate the C. acnes bacterial biofilm while limiting inactivation of co- habiting commensal bacteria and damage to surrounding tissues in a region of skin. Doing so specifically targets the acne forming bacteria without significant effect of tissue matrix or tissue mechanical properties.
Regarding claim 50, Yarmush teaches the method of claim 49, wherein the sub-microsecond pulsed electric field comprises an electric field strength from 0.1 kV/cm to 5 kV/cm ([abstract] To eradicate at least a portion of a biofilm on a medical implant, for example, 1500 volts can be applied through an electrode system) ([0010] The critical electric field strength (Ecr) needed to eradicate 100-80% of bacteria in such a treated area is expected to be between about 100 and 150 V/mm when 300 pulses are applied, and between about 225 and 250 V/mm when 150 pulses are applied). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Yarmush to include wherein the sub-microsecond pulsed electric field comprises an electric field strength from about 0.1 kV/cm to about 5 kV/cm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 51, Yarmush teaches the method of claim 39, wherein the sub-microsecond pulsed electric field has a frequency from 0.5 Hz to 10 Hz ([0010] a pulse delivery frequency of 2 Hz). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein the sub-microsecond pulsed electric field has a frequency from 0.5 Hz to 10 MHz, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 53, Yarmush teaches the method of claim 39, wherein inactivating the bacterial biofilm comprises disrupting, destroying, killing, or reducing the biofilm, and/or treating an infection ([0039] These experiments demonstrated that pulsed electric fields can eradicate bacteria and disrupt biofilms in mesh implants without damaging the mesh).
Regarding claim 54, Yarmush teaches the method of claim 39, but fails to teach wherein the bacterial biofilm comprises Gram-negative, Gram-positive, or mixed-species bacterial biofilms. However, Goldberg teaches wherein the bacterial biofilm comprises Gram-negative, Gram-positive, or mixed-species bacterial biofilms ([0104] The bioluminescent pathogenic Acinetobacter baumanii ATCC BAA 747 (ATCC, Manassas, Va.) gram (−) bacteria strain was used). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Yarmush to include wherein the bacterial biofilm comprises Gram-negative, Gram-positive, or mixed-species bacterial biofilms. Doing so targets a variety of bacteria stains for an effective treatment of acne.
Regarding claim 55, Yarmush teaches the method of claim 39, but fails to teach the method comprising applying the sub-microsecond pulsed electric field in proximity to the surface including the bacterial biofilm. However, Goldberg teaches the method comprising applying the sub-microsecond pulsed electric field in proximity to the surface including the bacterial biofilm ([abstract] Systems and methods for controlling a tissue of a subject using applied pulsed electric fields. The system for controlling a therapy provided to a tissue of a subject using applied pulsed electric fields. The system includes an electrode assembly configured to engage a skin tissue of a subject to deliver a series of electric field pulses to the skin tissue and a user input configured to receive an operational instruction for the series of electric field pulses). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Yarmush to include the method comprising applying the sub-microsecond pulsed electric field in proximity to the surface including the bacterial biofilm. Doing so allows for close proximity to the target site for an effective treatment of the biofilm.
Regarding claim 56, Yarmush teaches the method of claim 39, wherein applying the sub-microsecond pulsed electric field comprises applying an applicator designed to deliver the sub-microsecond pulsed electric field in proximity to the surface ([0022] The system 100 may have both the ability to apply pulsed electric fields externally via an extendible electrode system 170, as well as “internally” via the device receptacle 150, which may be an enclosure with one or more of its own electrodes for applying pulsed electric fields to devices placed in the receptacle 150).
Regarding claim 58, Yarmush teaches the method of claim 39, wherein the method is processor controlled ([0023] The processing unit 120 includes a processor, one or more memory modules, and instructions in the form of software (which can be loaded into the memory), firmware, hardware, or any combination thereof. The components of the processing unit 120 are involved in coordination and implementation of the functionality of the system 100 by, for example, interfacing with the pulse generator 110 to control the generation of pulsed electric fields, the user interface 130 to receive inputs).
Claim(s) 43 and 52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yarmush (US 20180250427 A1) in view of Goldberg (US 20160213922 A1), and Ivanova (US 20170312345 A1), further in view of Beebe (US 20060269531 A1).
Regarding claim 43, Yarmush teaches method of claim 39, but fails to teach wherein the sub-microsecond pulsed electric field has a pulse duration from 10 nanoseconds to 500 nanoseconds. However, Beebe teaches wherein the sub-microsecond pulsed electric field has a pulse duration from 10 nanoseconds to 500 nanoseconds ([0078] The second type of pulse has a duration in the nanosecond range (1 to 300 nanoseconds), and defined herein as a short pulse). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Yarmush to include wherein the sub-microsecond pulsed electric field has a pulse duration from 10 nanoseconds to 500 nanoseconds. Doing so results in a short pulse used for a specific outcome of the treatment on a bacterial biofilm. Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Yarmush to wherein the sub-microsecond pulsed electric field has a pulse duration from 10 nanoseconds to 500 nanoseconds, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 52, Yarmush teaches method of claim 39, but fails to teach wherein the sub-microsecond pulsed electric field has a pulse duration from 10 nanoseconds to 900 nanoseconds. However, Beebe teaches wherein the sub-microsecond pulsed electric field has a pulse duration from 10 nanoseconds to 500 nanoseconds ([0078] The second type of pulse has a duration in the nanosecond range (1 to 300 nanoseconds), and defined herein as a short pulse). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Yarmush to include wherein the sub-microsecond pulsed electric field has a pulse duration from 10 nanoseconds to 900 nanoseconds. Doing so results in a short pulse used for a specific outcome of the treatment on a bacterial biofilm. Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Yarmush to wherein the sub-microsecond pulsed electric field has a pulse duration from 10 nanoseconds to 900 nanoseconds, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 45 and 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yarmush (US 20180250427 A1) in view of Goldberg (US 20160213922 A1), and Ivanova (US 20170312345 A1), further in view of Jaynes (US 6303568 B1).
Regarding claim 45, Yarmush teaches method of claim 39, but fails to teach further comprising contacting the surface comprising the bacterial biofilm with lysozyme prior to applying the sub-microsecond pulsed electric field. However, Jaynes teaches further comprising contacting the surface comprising the bacterial biofilm with lysozyme prior to applying the sub-microsecond pulsed electric field (([20] Combinations of modified Cecropin C-37 and natural cecropin B with lysozyme at 10 micrograms, 1 milligram and 10 milligrams per milliliter were effective to prevent growth). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Yarmush to include further comprising contacting the surface comprising the bacterial biofilm with lysozyme prior to applying the sub-microsecond pulsed electric field. Doing so allows for the lysozyme to take effect in weakening the cell walls so the bacteria could be treated more effectively.
Regarding claim 46, Yarmush teaches method of claim 45, but fails to teach wherein contacting the surface comprising the bacterial biofilm comprises contacting the surface with lysozyme at a concentration from at least 1 mg/ml to 10 mg/ml in a liquid medium. However, Jaynes teaches wherein contacting the surface comprising the bacterial biofilm comprises contacting the surface with lysozyme at a concentration from at least 1 mg/ml to 10 mg/ml in a liquid medium (([20] Combinations of modified Cecropin C-37 and natural cecropin B with lysozyme at 10 micrograms, 1 milligram and 10 milligrams per milliliter were effective to prevent growth). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Yarmush to include wherein contacting the surface comprising the bacterial biofilm comprises contacting the surface with lysozyme at a concentration from at least 1 mg/ml to 10 mg/ml in a liquid medium. Doing so allows for the concentration of lysozyme to take effect in weakening the cell walls so the bacteria could be treated more effectively.
Claim(s) 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yarmush (US 20180250427 A1) in view of Goldberg (US 20160213922 A1), and Ivanova (US 20170312345 A1), further in view of Jaynes (US 6303568 B1), further in view of MacPhee (US 4755464 A).
Regarding claim 47, Yarmush teaches method of claim 45, but fails to teach wherein the surface comprising the bacterial biofilm is contacted with lysozyme for a period of time from 10 min to 1 h. However, MacPhee teaches wherein the surface comprising the bacterial biofilm is contacted with lysozyme for a period of time from 10 min to 1 h ([28] 3. To all cultures was added lysozyme, 30 .mu.l of 10 mg.ml.sup.-1. This was to weaken rather than break the cell walls. Each culture was then lysed by a 30 second burst (setting 3, high power, 4 microns) of an ultrasonic disintegrator. This was done on ice and the lysate immediately packed in ice) ([29] 4. 50 .mu.l lysate was added to 600 .mu.l of 1000 units and 200 units ml.sup.-1 sodium benzylpenicillin. This was left for one hour at 37.degree. C). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Yarmush to include wherein the surface comprising the bacterial biofilm is contacted with lysozyme for a period of time from 10 min to 1 h. Doing so allows for the lysozyme to take effect in weakening the cell walls so the bacteria could be treated more effectively.
Claim(s) 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yarmush (US 20180250427 A1) in view of Goldberg (US 20160213922 A1), and Ivanova (US 20170312345 A1), further in view of Vecchio (US 20180036552 A1).
Regarding claim 57, Yarmush teaches the method of claim 39, but fails to teach the method comprising reducing a population of bacteria by a factor of 10^2 to 10^4 and a population of the planktonic bacteria by less than a factor of 10.
However, Vecchio teaches method of claim 39, the method comprising reducing a population of bacteria by a factor of 10^2 to 10^4 ([0009] In one embodiment, the step of irradiating includes reducing the first amount of treated bacteria by a factor of M>N. Here, N is a factor of reduction of a second amount of treated bacteria as a result of irradiating a second amount of treated bacteria with the same light for the same pre-determined duration of time, while the second amount of treated bacteria is an amount formed as a result of establishing contact between only the first composition of matter and the target bacteria. M/N is at least 10; preferably at least 100; More preferably at least 1,000; and even more preferably, at least 10,000). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Yarmush to include the method comprising reducing a population of bacteria by a factor of 10^2 to 10^4. Doing so reduces the bacterial load of the biofilm by a significant amount. Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Yarmush to include the method comprising reducing a population of bacteria by a factor of 10^2 to 10^4, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Further, Ivanova teaches and a population of the planktonic bacteria by less than a factor of 10 ([0277] The inhibition of biofilm mass formation by about 90% to 92% (p<0.001, compared to the Control) and the full (100%) inhibition of bacterial cell viability (by Resazurin assay). It also completely abrogated bacterial cell growth in both populations of the cells by about 3.73 log in biofilm cells, and by about 3.31 log in planktonic cells from supernatant removed after 24 hour of incubation). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Yarmush to include reducing a population of the planktonic bacteria by less than a factor of 10. Doing so reduces the planktonic bacteria to a specific amount without completely eradicating it.
Conclusion
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
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