FINAL ACTION
Response to Arguments
Applicant's arguments filed February 17th, 2026 have been fully considered but they are not persuasive.
Applicant argues that:
Rovison Teaches Away from ≤100 ppm PAA.
Rovison is directed to sterilization using peracetic acid vapor and expressly teaches that, to obtain sufficient sterilization efficacy, the PAA concentration should be at least about 3,500 ppm (see, e.g., Rovison claim 1 and corresponding disclosure).
In direct contrast, amended claim 1 requires a PAA vapor concentration of 100 ppm or less.
Rovison's core teaching (invention) therefore drives the skilled artisan toward high PAA concentrations (≥3,500 ppm) as necessary for effective sterilization. Adopting Rovison's approach would lead away from, not toward, Applicant's extremely low concentration regime.
This is not a matter of routine optimization within a disclosed range. The claimed limitation defines an operating regime that is fundamentally inconsistent with Rovison's stated requirement for efficacy. Where the prior art emphasizes the necessity of high concentrations, it teaches away from drastically lower levels. Accordingly, Rovison does not provide a motivation to select ≤100 ppm PAA and instead discourages such selection.
Wiget’s Low-Concentration Disclosures Are Specific to VHP
Wiget is directed to low-concentration vaporized hydrogen peroxide (VHP) decontamination. Wiget provides detailed dose and condition data for VHP. Although Wiget lists peracetic acid as one of several alternative sterilants (e.g., claim 8), it does not provide teaching or guidance regarding:
How PAA should be controlled at low concentrations;
How PAA stability of decomposition should be addressed; or
How PAA efficacy would be maintained in a ≤100 ppm vapor regime.
PAA and VHP have materially different chemical properties, including differences in stability and decomposition behavior. A skilled artisan would not reasonably extrapolate Wiget's low-concentration VHP efficacy to PAA-particularly in view of Rovison's explicit teaching that effective PAA sterilization requires concentrations of at least about 3,500 ppm.
Thus, the Office's premise that one could simply substitute PAA for VHP in Wiget's low-concentration process lacks evidentiary support.
No Reasonable Expectation of Success
Even if one were to assume that substitution of PAA into Wiget's system would be contemplated, the cited art does not provide a reasonable expectation of success that PAA vapor at ≤100 ppm would achieve adequate decontamination.
Rovison expressly indicates that effective sterilization requires PAA concentrations at least about 3,500 ppm. This teaching would undermine any reasonable expectation that concentrations thirty-five times lower (≤100 ppm) would be effective.
Furthermore, amended claim 1 requires a specific combination of limitations, including:
1. Non-mist PAA vapor release;
2. An average humidity of RH 82% or more
3. A defined vapor load (minute-by-minute cumulative sum ≥2000 ppm); and
4. A PAA concentration of <100 ppm.
The cited references do not teach or suggest this combination. The Office's reasoning effectively reconstructs the claimed invention using Applicant's disclosure as a blueprint, which is impermissible hindsight.
The Examiner would respectfully respond that:
It is extremely important to first note that Rovison is not relied upon for a teaching of the concentration of peracetic acid in the released vapor being 100 ppm or less. Wiget is relied upon for this information. Furthermore, Wiget specifically discloses that the target concentration of the decontaminating vapor be between about 25-50 ppm in order to maximize the material compatibility between said decontaminating vapor and the items being decontaminated (See paragraph 42), so much so that Wiget specifically claims as such (See claims 2 & 3). Wiget discloses that the concentration must remain low because the items being subjected to the decontamination procedure can be adversely affected by stringent conditions such as higher temperatures, extreme humidities, and high concentrations of the decontaminating vapor (paragraphs 3-5, 8 and 9). As such, one of ordinary skill starting with any type of decontaminating vapor, in which Wiget discloses peracetic acid to be one utilized in the method (paragraph 17; claim 8), would choose to keep said concentration of the decontaminating vapor below 100 ppm because Wiget specifically discloses that said concentration should be between 25-50 ppm (paragraph 42) because the items being decontaminated can be adversely affected by decontaminating vapors with higher concentrations (paragraphs 3-5, 8 and 9).
To the response that Rovison teaches away from ≤100 ppm PAA, it is the position of the Office that the reference of Rovison does not disclose that the concentration of the peracetic acid in the released vapor is greater than 3,500 ppm. As set forth in paragraph 12 of Rovison, the aqueous peracetic acid is diluted to 3,500 ppm with water to provide a solution. That 3,500 ppm solution is then added to a heated flow gas stream at 5mL/min, in which the gas stream has a flow rate of 30 L/min (or 30,000 mL/min). Thus, 5 mL of 3,500 ppm peracetic acid solution being added to 30,000 mL of a gas would lead to a total concentration of said peracetic acid in the released gas vapor stream to be far below 3,500 ppm. Nonetheless, as noted above, Rovison is not relied upon for this teaching, as Wiget discloses the importance of the decontaminating vapor to be between 25-50 ppm in order to prevent adversely affecting the items being decontaminated by the decontaminating vapor.
To the remark regarding that Wiget’s low concentration disclosures are specific to VHP, as noted above, Wiget specifically discloses that the concentration of the decontaminating vapor must remain low because the items being subjected to the decontamination procedure can be adversely affected by stringent conditions such as higher temperatures, extreme humidities, and high concentrations of the decontaminating vapor (paragraphs 3-5, 8 and 9). As such, one of ordinary skill starting with any type of decontaminating vapor, in which Wiget discloses peracetic acid to be one utilized in the method (paragraph 17; claim 8), would choose to keep said concentration of the decontaminating vapor below 100 ppm because Wiget specifically discloses that said concentration should be between 25-50 ppm (paragraph 42) because the items being decontaminated can be adversely affected by decontaminating vapors with higher concentrations (paragraphs 3-5, 8 and 9).
Further regarding the remark of no reasonable expectation of success, the targeted dose for the item being decontaminated as set forth in Wiget is at least 1,300 ppm, and most often greater than 2,000 ppm (Table 1), not ≤100 ppm. This is done by continuously feeding the decontaminating vapor to the item in concentrations of 25-50 ppm until the target does is achieved to decontaminate the item (Table 1). Still further, Wiget clearly discloses the use of peracetic acid as an alternative decontaminant (paragraph 17; claim 8), and clearly discloses throughout the entire disclosure of decontaminating items utilizing a vaporous decontaminant at concentrations of 25-50 ppm to reach a targeted dose of at least 1,300 ppm, and most often greater than 2,000 ppm to successfully decontaminate the items. As such, it would seem pretty clear that one of ordinary skill would reasonably expect to successfully decontaminate items with peracetic acid in the method provided by Wiget because of the disclosures set forth therein.
Because of the explanations provided by the Examiner above, this response is deemed to be not persuasive, and the claims remain unpatentable over Wiget in view of Rovison as set forth below.
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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Wiget et al. (U.S. Publication No. 2015/0265738) in view of Rovison, JR. et al. (U.S. Publication No. 2012/0189494).
Wiget discloses a decontamination method for decontaminating an inside of a decontamination target (i.e., isolator or room or object in room) by removing at least one of a microorganism and a virus present in the decontamination target (Abstract; Figure 1), the method comprising:
Releasing vapor containing peracetic acid into the decontamination target, without releasing mist containing peracetic acid (paragraph 17), wherein an average humidity inside the decontamination target during decontamination is RH82% or more (Table 1, Test Run # 10);
Wherein a vapor load that is a value obtained by adding a concentration of the vapor every minute (Table 1 Dose Set Point is ppm*min; paragraph 52) from a start of the decontamination to a completion of the decontamination is 2,000 ppm or more (See Table 1, Test Run #’s 3, 4, 7, 8 and 12); and
Wherein the concentration of the vapor in the released vapor is 100 ppm or less (Table 1; paragraph 55; claim 3).
Wiget does not appear to specifically disclose that the vapor load that is a value obtained by adding a concentration of the vapor every minute from a start of the decontamination to a completion of the decontamination of being 2,000 ppm or more is peracetic acid. Rovison discloses a method of decontaminating the inside of a target object in which the method releases vapor containing a decontaminant into the target object without releasing a mist (paragraph 9) of the decontaminant to sterilize said object (Abstract). The reference continues to disclose that the decontaminant is a peracetic acid vapor in which the method further comprises a peracetic acid vapor load that is a value obtained by adding a concentration of peracetic acid in the vapor every minute (paragraph 20) from a start of the decontamination to a completion of the decontamination is 2000 ppm or more in order to effectively decontaminate target object with a safe decontaminant such as peracetic acid that doesn’t produce undesirably high residues on said target object (paragraphs 3-7). As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a peracetic acid vapor in Wiget in such a way that the peracetic acid vapor load is a value obtained by adding a concentration of peracetic acid in the vapor every minute from a start of the decontamination to a completion of the decontamination to be 2000 ppm or more in order to effectively decontaminate target object with a safe decontaminant such as peracetic acid that doesn’t produce undesirably high residues on said target object as exemplified by Rovison.
Thus, claim 1 is not patentable over Wiget in view of Rovison.
Concerning claim 2, Wiget continues to disclose that the average humidity is RH 99% or less (Table 1), and the peracetic acid vapor load is 12,000ppm or less (Table 1 of Wiget; paragraph 12 of Rovison).
Therefore, claim 2 is also not patentable over Wiget in view of Rovison.
Regarding claim 3, Wiget in view of Rovison also disclose that the peracetic acid vapor load and the average humidity satisfy the relationship y>-350x + 33250 in which x is the average humidity and y is the peracetic acid vapor load (Table 1 of Wiget; paragraph 12 of Rovison).
Thus, claim 3 is further not patentable over Wiget in view of Rovison.
With respect to claims 4 & 5, Wiget in view of Rovison further discloses that the vapor is released for 50% or more of a time period from the start of the decontamination to the completion of the decontamination, and/or the longest time period of a time period during which the vapor is continuously released is 50% or more of a time period from the start of the decontamination to the completion of the decontamination (paragraphs 39-41 of Wiget; paragraph 20 of Rovison). Therefore, claims 4 & 5 are also not patentable over Wiget in view of Rovison.
Nonetheless, for further prosecution, it also noted that the Courts have 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." See In re Aller, 220 F.2d 454, 456,105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). In this respect it would have been well within the purview of one of ordinary skill in the art to release the vapor for 50% or more of a time period from the start of the decontamination to the completion of the decontamination, and/or the longest time period of a time period during which the vapor is continuously released is 50% or more of a time period from the start of the decontamination to the completion of the decontamination in order to appropriately produce the desired concentration of the peracetic acid vapor on the target object for successful decontamination for a particular application based on various variables such as size of the enclosure, type of object being decontaminated, humidity, temperature etc.; as such is considered a result effective variable that one of ordinary skill would optimize through routine experimentation. Thus, claims 4 & 5 are not patentable over Wiget in view of Rovison in this respect as well.
Conclusion
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 KEVIN C JOYNER whose telephone number is (571)272-2709. The examiner can normally be reached Monday-Friday 8:00AM-4:30PM.
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, MICHAEL MARCHESCHI can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KEVIN JOYNER/Primary Examiner, Art Unit 1799
Prosecution Insights