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 1-12 are cancelled.
Claims 13-15 are pending. Applicant’s amendment has necessitated modification of the existing rejection. Accordingly, this Action is FINAL.
Withdrawn rejections
Applicant's amendments and arguments filed 12/1/25 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn. Claim 4 was rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph; claim 6 was rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph; claim 6 was rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph; claim(s) 1-3 and 6-11 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ikawa et al. (US20100209293); and claims 4-5 were rejected under 35 U.S.C. 103(a) as being unpatentable over Ikawa et al. (US20100209293), as applied to claims 1-3 and 6-12 above, as evidenced by Merenyi et al. (PNAS 2000;97(15):8216-8218). Applicant has cancelled these claims thereby rendering the rejections moot.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Ikawa et al. (US20100209293) as evidenced by Merenyi et al. (PNAS 2000;97(15):8216-8218).
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103.
Applicant claims, for example:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a pharmaceutical antimicrobial formulation research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from pharmaceutical antimicrobial compositions, compounds and methods of producing those compositions— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claim 13, Ikawa et al. disclose liquid solutions of pH 4.8 and lower comprising nitrogen and oxygen radical active species such as nitric oxide and hydroxyperoxy radicals generated by plasma that become peroxynitrite (Abstract; [0075-0076]; claims 11-12), thereby producing plasma radical solutions. Figure 2 is demonstrative:
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Sterilization of any one or more of gram-positive bacteria claimed, gram negative bacteria claimed, fungi including Candida and Aspergillus and viruses including influenza virus, is inherent in the prepared prior art plasma radical solution. Ikawa et al. disclose as much in [0054]. The Examiner's finding is based on the principle that products of identical chemical compositions cannot have mutually exclusive properties. This is a well settled principle in patent law. See In re Papesch, 315 F.2d 381,391 (CCPA 1963) ("From the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing."). Consequently, it is inherent in the plasma radical solution of Ikawa et al. to have a sterilizing effect on any one or more of bacteria, fungi and viruses at an adjusted pH 0 to 4, with the sterilizing effect including any one or more of gram positive bacteria and gram negative bacteria, and wherein the gram positive bacteria may include any one or more of Staphylococcus aureus, Bacillus cereus, Bacillus subtilis, Enterococcus, Streptococcus, and Lactococcus, and the gram negative bacteria may include any one or more of Escherichia coli, Salmonella typhimurium, Pseudomonas aeruginosa, Klebsiella pneumonia, Haemophilus influenzae, Enterobacter aerogenes and Yersinia pesti, fungi consisting of Chytridiomycota, Zygomycota, Ascomycota, Basidiomycota, and Deuteromycota, and wherein the plasma radical solution has a sterilizing effect against the virus containing an influenza virus. Such sterilization of the claimed microorganisms naturally flows from the plasma radical solution prepared by Ikawa et al. at the same pH and containing peroxynitrite.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Ikawa et al. is that Ikawa et al. do not expressly teach the claimed method for preparing a plasma radical solution as claimed. However, Ikawa et al. do teach obtaining a liquid in need of sterilization [0054], adjusting the pH to 4.8 or lower [0050, 0055-0056, 0067, 0072], contacting the liquid with plasma PM [0058] (Figures 2-4), that generates reactive nitrogen and oxygen species including peroxynitrite (Abstract; [0075]), where the corona discharge applied determines the distribution of ions [0233], which dissolve in the aqueous solvent (Figure 1-2). Ikawa et al. teach an embodiment where nitric acid or nitrate powder is dissolved in the liquid to generate nitrogen species [0061] and Ikawa et al. teach an embodiment where the plasma generating device has an electrode arranged in the liquid to generate plasma PM in the liquid LQ [0058], which ostensibly results in bubbling. Where patentability rests upon a property of the claimed method, in this case “bubbling”, not disclosed within the art, the USPTO has no reasonable method of determining whether there is, in fact, a patentable difference between the prior art materials and the claimed material. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Therefore, where the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the USPTO can require an applicant to prove that the prior art products do not necessarily possess the bubbling characteristics of his claimed method. Id.
A pH of 4.8 or lower overlaps the claimed range of 0 to 4. See MPEP 2144.05(I): In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Ikawa et al. provide a flow chart where the liquid is prepared, then pH adjusted, then brought into contact with plasma (Figures 5-6). While Ikawa et al. do not expressly teach adjusting the pH of the solution as a final step, but please note MPEP 2144.04 IV: “See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results). Consequently, the claimed method is obvious over the teachings of Ikawa et al. in the absence of evidence to the contrary. The Examiner also notes that Ikawa et al. also teach embodiment of producing a sterilizing liquid to treat wounds on a human body (Claim 7; [0144]).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments:
Applicant’s arguments filed on 12/1/25 have been carefully considered but are not persuasive.
Applicant asserts that Ikawa et al. fails to disclose, suggest or render obvious steps (c) and (d). Respectfully, the Examiner has a different perspective. The Examiner has shown above that Ikawa et al. suggests an embodiment where bubbling naturally flows from the method and that the pH is adjusted to overlap the claimed range. Applicant has produced no evidence or articulated reasoning to the contrary. Applicant has also failed to produce any evidence that through the action of bubbling the oxidized active species are dissolved in the solvent imparts any unexpected result. Since the method of Ikawa et al. produces a plasma radical solution with the same components at the same pH, then it must also be characterized by sterilizing the same bacteria, fungi and viruses claimed. Such action naturally flows from having prepared the same plasma radical solution including peroxynitrite. Respectfully, Applicant’s arguments have been carefully considered but are not persuasive.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Y Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613