CTNF 18/570,719 CTNF 89204 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Preliminary amendments filed 12/15/2023 are acknowledged. Claims 1-20 are pending. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. 07-15-aia AIA Claim(s) 1-8, 10, 12, 13, 15-17, and 20 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Voyten et al. (US 2005/0260096) . With regards to claim 1, Voyten et al. teaches a process for sterilization or disinfection comprising: obtaining a hydrogen peroxide vapor from an aqueous hydrogen peroxide solution (abstract; para [0024]-[0025]). Given that Voyten teaches the sterilization solution is distilled or deionized water and hydrogen peroxide it is taken that those two compounds are all that is present (water and hydrogen peroxide) (para [0024]-[0025]). A solution of just water and hydrogen peroxide contains no stabilizer, no metals, and has a dry residue as claimed regardless of the way they are measured. Voyten et al. teaches sterilizing or disinfecting an object with the hydrogen peroxide vapor (para [0023]). With regards to claim 2, a mixture of water and hydrogen peroxide has a residue of 0 which is below the detectable level. With regards to claim 3, no stabilizers is less than 1 ppm. With regards to claim 4, a composition of only water and hydrogen peroxide has a content of metals less than 4 ppb no matter the method used to measure. With regards to claim 5, a composition of only water and hydrogen peroxide has a content of Cu less than 0.2 ppb no matter the method used to measure. With regards to claim 6, a composition of only water and hydrogen peroxide has a content of metals less than 20 ppb no matter the method used to measure. With regards to claims 7 and 8, the stability of the solution is an inherent chemical property. Since the prior art teaches a substantially similar solution to the present disclosure of water, hydrogen peroxide, no stabilizers, and no metals, the prior art is taken to meet the claimed stability. With regards to claim 10, the obtaining of the hydrogen peroxide solution is not an active method step of the method of sterilizing. Thus, how the hydrogen peroxide is obtained is being treated like a product by process limitation. The prior art teaches a similar pure solution of hydrogen peroxide and water. With regards to claim 12, the hydrogen peroxide vapor is produced by evaporation or vaporization of the aqueous hydrogen peroxide solution (abstract). With regards to claim 13, Voyten et al. teaches that the object can be objects (articles) (para [0023]). With regards to claim 15, no stabilizers is essentially 0 or 0. With regards to claim 16, a composition of only water and hydrogen peroxide has a content of Cu less than 0.1 ppb no matter the method used to measure. With regards to claims 17 and 20, the stability of the solution is an inherent chemical property. Since the prior art teaches a substantially similar solution to the present disclosure of water, hydrogen peroxide, no stabilizers, and no metals, the prior art is taken to meet the claimed stability . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-22-aia AIA Claim (s) 11 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Voyten et al. (US 2005/0260096) as applied to claim 1 above, and further in view of Centanni (US 2005/0276721) . With regards to claims 11 and 19, Voyten et al. is silent as to the concentration of the aqueous hydrogen peroxide solution. Centanni teaches a method and apparatus for sterilizing using a hydrogen peroxide in water solution (abstract; para [0091]-[0094]). Centanni teaches using hydrogen peroxide in liquid solution with water in a range of about 35% to 50% as well as 25% to 65% (para [0091]). A person having ordinary skill in the art would have found it obvious to have used the aqueous hydrogen peroxide in an amount as taught by Centanni motivated by an expectation of successfully providing a liquid source for the vaporized hydrogen peroxide sterilization. The taught ranges coincide and overlap with the ranges claimed . 07-22-aia AIA Claim (s) 9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Voyten et al. (US 2005/0260096) as applied to claim 1 above, and further in view of USP Technologies . With regards to claims 9 and 18, Voyten does not specify the pH of the hydrogen peroxide in water solution. USP teaches that while the pH of hydrogen peroxide and water solutions vary based on a variety of factors most concentrated products are at a pH of 1-4 (including 2-4 when the hydrogen peroxide is produced from auto oxidation of anthraquinones) and that lower pH solutions are more stable (see whole document). A person having ordinary skill in the art would have found it obvious to have used solutions at the pH claimed and optimize the pH in order to get the desired stability in the peroxide solution . 07-22-aia AIA Claim (s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Voyten et al. (US 2005/0260096) as applied to claim 1 above, and further in view of Benedetti et al. (US 2005/0198924) . With regards to claim 14, Voynten does not limit the sterilization process in which the vapor hydrogen peroxide is used. Benedetti teaches an aseptic packing process and teaches using vapor hydrogen peroxide. The containers are preheated to above the vapor condensation point of the hydrogen pereoxide in a range of 50-95C in order to prevent condensation (para [0008], [0010], [0030]-[0035]). A person having ordinary skill in the art would have found it obvious to have used the hydrogen peroxide vapor in an aseptic container packaging method where the containers are at temperatures above the condensation point of the hydrogen peroxide vapor including 50-95C motivated by an expectation of successfully providing sterile packaging without undesired vapor condensation. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to DONALD R SPAMER whose telephone number is (571)272-3197. The examiner can normally be reached Monday to Friday from 9-5. 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. /DONALD R SPAMER/Primary Examiner, Art Unit 1799 Application/Control Number: 18/570,719 Page 2 Art Unit: 1799 Application/Control Number: 18/570,719 Page 3 Art Unit: 1799 Application/Control Number: 18/570,719 Page 4 Art Unit: 1799 Application/Control Number: 18/570,719 Page 5 Art Unit: 1799