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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/27/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 4 and 8-9 are objected to because of the following informalities:
Claim 4 recites “wherein the fluid is a liquid”; however, claim 1, from which claim 4 depends, recites that the fluid is an “aqueous fluid” and it is understood that an aqueous fluid can be nothing other than a liquid. Therefore, it is recommended to amend claim 4 to include subject matter that further limits the invention of claim 1, as the subject matter of the fluid being a liquid appears to already be recited implicitly within claim 1.
Claim 8 recites “wherein the plasma is a non-thermal plasma having an intensity…”; however, claim 1 from which claim 8 depends, already states that the plasma is a non-thermal plasma. It is recommended to amend claim 8 so as to read “the has an intensity…” or similar.
It is believed claim 9 should read “wherein the fluid is contacted with the non-thermal plasma for a time in a range of from about 5 seconds to about 5 minutes.” or similar.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10-12 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 10 recites the limitation "the irrigating" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 10 depends, recites contacting rather than irrigating.
Claim 11 recites the limitation "the irrigating" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 11 depends, recites contacting rather than irrigating.
Claim 12 recites the limitation "the irrigating" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 12 depends, recites contacting rather than irrigating.
For the purpose of examination on the merits, each of claims 10, 11, and 12 will be interpreted as reciting contacting rather than irrigating.
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.
Claims 1 and 4-15 are rejected under 35 U.S.C. 103 as being unpatentable over Slipenicaia et al. (The treatment of herpetic keratitis using the ionoplasmic coagulation of the cornea) (English translation) (already of record) in view of Fridman et al. (WO 2012/018891 A2) (already of record).
Regarding claim 1, Slipenicaia et al. discloses a method of treating herpes keratitis (Abstract) comprising contacting an eye of a patient in need of such treatment with a non-thermal plasma (Abstract, p. 5 para. 1-4).
Slipenicaia et al. is silent as to the method comprising contacting the eye of the patient in need of such treatment with a disinfecting aqueous fluid, the aqueous fluid being previously contacted with the non-thermal plasma.
Fridman et al. discloses that both direct plasma application (where plasma is applied directly to the material to be treated) and indirect plasma application (where a solution previously contacted with a plasma is applied to the material to be treated) were known in the art of material treatment (e.g., disinfection) (para. 3, 86, 91, 167). As an example of the indirect technique, Fridman et al. discloses contacting an aqueous fluid such as an aqueous liquid comprising phosphate buffered saline (para. 86, 95) with a non-thermal plasma derived from dielectric barrier discharge (para. 24, 84-86) to thereby arrive at a disinfecting aqueous fluid (Abstract), and subsequently contacting the aqueous fluid with a material in need of treatment, such as a living tissue of a human (para. 11, claims 16-17).
Fridman et al. discloses that the treatment is effective to kill bacteria on the material because contacting the fluid with the plasma imparts reactive oxygen species into the fluid (para. 86); thus the mechanism of pathogen destruction is the same as that of the method disclosed by Slipenicaia et al. which also applies reactive oxygen species generated via plasma (p. 5 para. 4).
Furthermore, Fridman et al. discloses that the indirect application technique has benefits as compared to the direct application technique, including allowing the plasma-treated fluid to be formed and transported to a different location (para. 91), allowing the plasma-treated fluid to be formed ahead of time and used on a surface at a later time (para. 91), and enhancing ease of use by using a liquid which can more easily be applied to a surface in need of treatment (para. 96).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the method disclosed by Slipenicaia et al. to comprise contacting the eye of the patient in need of treatment with a disinfecting aqueous fluid that has been previously contacted with the non-thermal plasma, e.g., by contacting with an aqueous fluid comprising a liquid comprising phosphate buffered saline that has been previously contacted with a non-thermal plasma derived from dielectric barrier discharge, as Fridman et al. discloses that it was known in the art to use such a technique to destroy pathogens on living tissue using the same mechanism (reactive oxygen species) already disclosed by Slipenicaia et al., while obtaining the benefits of allowing the treatment fluid to be formed ahead of time at a convenient location and enhancing ease of use by using a liquid treatment as discussed above.
Regarding claim 4, Slipenicaia et al. in view of Fridman et al. teaches wherein the fluid is a liquid, as set forth above.
Regarding claim 5, Slipenicaia et al. in view of Fridman et al. teaches wherein the fluid is a liquid, as set forth above, and Fridman et al. further discloses wherein the fluid is a misted liquid (para. 111), and therefore the prior art combination arrives at the claimed subject matter.
Regarding claim 6, Slipenicaia et al. in view of Fridman et al. teaches wherein the aqueous fluid comprises phosphate buffered saline, as set forth above.
Regarding claim 7, Slipenicaia et al. in view of Fridman et al. teaches wherein the non-thermal plasma is derived from a dielectric barrier discharge, as set forth above.
Regarding claim 8, Slipenicaia et al. in view of Fridman et al. teaches the fluid that has been previously contacted with a non-thermal plasma, as set forth above, and Fridman et al. further discloses wherein the non-thermal plasma has an intensity of at least about 0.1 J/cm2 at the surface of a plasma source electrode (para. 15, 87), and therefore the prior art combination arrives at the claimed subject matter.
Regarding claim 9, Slipenicaia et al. in view of Fridman et al. teaches the fluid that has been previously contacted with a non-thermal plasma, as set forth above, and Fridman et al. further discloses wherein the fluid is contacted with the non-thermal plasma for 60 seconds (falls within the claim range) (para. 126) (Fig. 12, sheet 12 of 34), and therefore the prior art combination arrives at the claimed subject matter.
Regarding claim 10, Slipenicaia et al. in view of Fridman et al. teaches the fluid that has been previously contacted with a non-thermal plasma, as set forth above, and Fridman et al. further discloses wherein the material to be treated is contacted 60 seconds (falls within the claim range) after the fluid has been contacted with the non-thermal plasma (para. 95, 126) (Fig. 12, sheet 12 of 34), and therefore the prior art combination arrives at the claimed subject matter.
Regarding claim 11, Slipenicaia et al. in view of Fridman et al. teaches the fluid that has been previously contacted with a non-thermal plasma, as set forth above, and Fridman et al. further discloses wherein the contacting is done for a period of 10 seconds (falls within the claim range) (para. 95, 126) (Fig. 12, sheet 12 of 34), and therefore the prior art combination arrives at the claimed subject matter.
Regarding claim 12, Slipenicaia et al. in view of Fridman et al. teaches contacting the eye with the fluid, as set forth above.
The prior art combination is silent as to the contacting being done two or more times.
Nonetheless, it is well established that mere duplication of a step is a prima facie obvious modification (MPEP 2144.04). Modifying the method taught by the prior art combination such that the contacting is done two more times would require mere duplication of the contacting step already taught by the prior art, and would be prima facie obvious absent persuasive evidence that a new and unexpected result is produced. The skilled artisan would recognize that adding an additional contacting step would yield the predictable outcome of enhancing contact between the eye and the treatment fluid, thereby providing an increased disinfection effect.
Regarding claim 13, Slipenicaia et al. in view of Fridman et al. teaches wherein the non-thermal plasma is derived from a dielectric barrier discharge, as set forth above.
Regarding claim 14, Slipenicaia et al. in view of Fridman et al. teaches the fluid that has been previously contacted with a non-thermal plasma, as set forth above, and Fridman et al. further discloses wherein non-thermal plasma is generated using a configuration providing a frequency in a range of 0.5 kHz to about 500 kHz (para. 87). Fridman et al. does not expressly disclose a maximum frequency in a range of from about 0.5 to about 2 kHz; nonetheless, it has been held that in the case where a claimed range overlaps or lies inside a range disclosed by the prior art, a prima facie case of obviousness exists (MPEP §2144.05). It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention generate the non-thermal plasma using a configuration providing a maximum frequency of from about 0.5 to about 2 kHz, as Fridman et al. discloses that configurations having a frequency in an overlapping range were suitable for generating a non-thermal plasma.
Regarding claim 15, Slipenicaia et al. in view of Fridman et al. teaches the fluid that has been previously contacted with a non-thermal plasma, as set forth above, and Fridman et al. further discloses wherein the non-thermal plasma is generated using a configuration providing an amplitude of about 10kV (falls within the claim range) (para. 85, 88), and therefore the prior art combination arrives at the claimed subject matter.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Slipenicaia et al. (The treatment of herpetic keratitis using the ionoplasmic coagulation of the cornea) (English translation) (already of record) in view of Fridman et al. (WO 2012018891 A2) (already of record), or alternatively, Slipenicaia et al. (The treatment of herpetic keratitis using the ionoplasmic coagulation of the cornea) (English translation) (already of record) in view of Fridman et al. (WO 2012018891 A2) (already of record) and in further view of LeBlanc et al. (Treatment of HSV-1 Infection with Immunoglobulin or Acyclovir: Comparison of Their Effects on Viral Spread, Latency, and Reactivation) (already of record).
Regarding claim 2, the claim is directed to wherein the treating reduces the number of HSV-1 genome copies in the eye relative to the number of HSV-1 genome copies without treatment. This is understood to be an inherent result of the process. It has been held that, under the principles of inherency, where the claimed and prior art products are identical or substantially identical in structure of composition, claimed properties or functions are presumed to be inherent (MPEP 2112). Slipenicaia et al. in view of Fridman et al. does not expressly teach wherein the treating reduces the number of HSV-1 genome copies in the eye relative to the number of HSV-1 genome copies without treatment; however, the prior art fluid used to treat the eye is the same as that claimed. Specifically, the prior art fluid is a liquid comprising phosphate buffered saline that has been previously contacted with a non-thermal plasma derived from dielectric barrier discharge, as discussed above, and this is the same product as is detailed in Applicant’s specification as filed (see para. 71-73 of the specification). Furthermore, the prior art is applied in the same manner as is detailed in Applicant’s specification as filed (Fridman et al. discloses contacting the surface to be treated for at least about 600 seconds, para. 93, which is at least as long as Applicant’s contact time of 1 minute or 5 minutes as detailed in para. 73 of the specification). Therefore, the claimed result of reducing the number of HSV-1 genome copies in the eye is presumed to be inherent in the method taught by the prior art, and the burden is shifted to Applicant to prove that the prior art application does not inherently possess the characteristic of reducing the number of HSV-1 genome copies in the eye to which the product is applied.
Should it be found that this effect is not inherent to the method taught by the prior art as embodied by Slipenicaia et al. in view of Fridman et al., then it nonetheless would have been obvious to modify the prior art combination to include this subject matter.
LeBlanc et al. discloses a method of treating HSV-1 infection comprising treating an eye of a subject in need of such treatment with an antiviral therapy (Abstract) and further discloses that it is desirable to reduce the number of HSV-1 genome copies in the eye via the treatment in order to reduce levels of latent reinfection and reactivation (Abstract).
Furthermore, Fridman et al. discloses that the biocidal effect of the fluid is increased with increased contact time with the material to be treated (para. 138).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the method taught by Slipenicaia et al. in view of Fridman et al. such that the treating reduces the number of HSV-1 genome copies in the eyes relative to the number without treatment, because LeBlanc et al. discloses that a lowered number of HSV-1 genome copies in a subject’s eye is associated with reduced latent reinfection and reactivation, and the skilled artisan would have been motivated to prevent latent reinfection and reactivation of herpes keratitis in the patient. It would have been well within the purview of the skilled artisan to seek to reduce the number of virus genome copies in the eye by increasing the biocidal effect of the fluid, e.g., by increasing the contact time with the eye, based on the teachings of the prior art.
Regarding claim 3, the claim is directed to wherein the treating reduces the number of HSV-1 genome copies in the eye by at least 20% relative to the number of HSV-1 genome copies without treatment. This is understood to be an inherent result of the process. It has been held that, under the principles of inherency, where the claimed and prior art products are identical or substantially identical in structure of composition, claimed properties or functions are presumed to be inherent (MPEP 2112). Slipenicaia et al. in view of Fridman et al. does not expressly teach wherein the treating reduces the number of HSV-1 genome copies in the eye by at least 20% relative to the number of HSV-1 genome copies without treatment; however, the prior art fluid used to treat the eye is the same as that claimed. Specifically, the prior art fluid is a liquid comprising phosphate buffered saline that has been previously contacted with a non-thermal plasma derived from dielectric barrier discharge, as discussed above, and this is the same product as is detailed in Applicant’s specification as filed (see para. 71-73 of the specification). Furthermore, the prior art is applied in the same manner as is detailed in Applicant’s specification as filed (Fridman et al. discloses contacting the surface to be treated for at last about 600 seconds, para. 93, which is at least as long as Applicant’s contact time of 1 minute of 5 minutes as detailed in para. 73 of the specification). Therefore, the claimed result of reducing the number of HSV-1 genome copies in the eye by at least 20% is presumed to be inherent in the method taught by the prior art, and the burden is shifted to Applicant to prove that the prior art application does not inherently possess the characteristic of reducing the number of HSV-1 genome copies by at least 20% in the eye to which the product is applied.
Should it be found that this effect is not inherent to the method taught by the prior art as embodied by Slipenicaia et al. in view of Fridman et al., then it nonetheless would have been obvious to modify the prior art combination to include this subject matter.
LeBlanc et al. discloses a method of treating HSV-1 infection comprising treating an eye of a subject in need of such treatment with an antiviral therapy (Abstract) and further discloses that it is desirable to reduce the number of HSV-1 genome copies in the eye via the treatment in order to reduce levels of latent reinfection and reactivation (Abstract).
Furthermore, Fridman et al. discloses that the biocidal effect of the fluid is increased with increased contact time with the material to be treated (para. 138), and Fridman et al. discloses general conditions for the percentage of pathogens killed after treatment with a plasma-contacted fluid (para. 165).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the method taught by Slipenicaia et al. in view of Fridman et al. such that the treating reduces the number of HSV-1 genome copies in the eyes relative to the number without treatment, because LeBlanc et al. discloses that a lowered number of HSV-1 genome copies in a subject’s eye is associated with reduced latent reinfection and reactivation, and the skilled artisan would have been motivated to prevent latent reinfection and reactivation of herpes keratitis in the patient. As to the specific reduction range of at least 20%, it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation, when the particular parameter is recognized as a result-effective variable (MPEP §2144.05). Fridman et al. discloses general conditions for a level of pathogen reduction and a means for increasing the level of pathogen reduction achieved, as discussed above. It would have been well within the purview of the skilled artisan to seek to modify the prior art method to reduce the number of virus genome copies in the eye by a desired amount by increasing the biocidal effect of the fluid, e.g., by increasing the contact time with the eye, based on the teachings of the prior art.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Ye et al. (Treatment of oral pathogenic bacteria with non-thermal plasma activated water as a new type mouthwash) is directed to a disinfecting aqueous fluid which has been previously contacted with a non-thermal plasma, the disinfecting aqueous fluid intended to be used to contact the mouth tissue of a person in need of disinfection treatment.
Conclusion
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/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799