FINAL ACTION
Claim Status
Claims 1-3, 6-16, 19 and 20 are pending. Claims 9-15 are withdrawn as being directed to a non-elected invention. Claims 1-3, 6-8, 16, 19 and 20 are up for examination.
Response to Arguments
Applicant's arguments filed November 3rd, 2025 have been fully considered but they are not persuasive.
Applicant argues that:
The claims have been amended to require that the spout have an opened position and a closed position. It is respectfully submitted that the cited art fails to teach the claimed invention.
The Examiner would respectfully contend that:
The reference of Vellutato discloses that the spout has an opened position and a closed position. As best shown in Figure 3, in which Figure 1 will perform in the exact same manner, the spout (18/66) has an opened position when the cap (28/68), and element (30/80) is removed therefrom as best shown in Figure 3; and the spout has a closed position when the cap (28/68) and element (30/80) is inserted therein as best shown in Figures 1 & 2. As such, Vellutato the newly provided limitations.
Therefore, this response is not persuasive.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 6-8, 16, 19 and 20 are rejected under 35 U.S.C. 103(a) as being unpatentable over Vellutato (U.S. Patent No. 6,123,900) in view of Leoncavallo (U.S. Patent No. 6,305,576) and Carpenter (U.S. Patent No. 6,150,423).
Regarding claims 1, 6, 16 and 19, Vellutato discloses a method of sterilizing a chemical composition (column 6, lines 45-67; column 7, lines 1-6) comprising the steps of:
Providing a first container with a first chemical composition (column 1, lines 60-65);
Sealing the first container in a first sealing layer to form a first sealed container enclosure (column 1, lines 60-65);
Enclosing said first sealed container enclosure in a shipping container to form a closed shipping package (column 4, lines 46-64); and
Externally irradiating said closed shipping package at a predetermined radiation level for a predetermined time interval to simultaneously sterilize said first chemical composition, said first container, said first sealed container enclosure, and said closed shipping package (column 5, lines 1-32) as disclosed in column 6 lines 45-67 and column 7 lines 1-6.
Vellutato does not appear to disclose that the process comprises a second container with a second chemical composition, wherein the first container is positioned with respect to the second container so that the first chemical composition is maintained apart from said second chemical composition, but can be combined with the second chemical composition. However, it is generally known in the art of dispensing to utilize a first container that is positioned with respect to the second container so that the first chemical composition is maintained apart from said second chemical composition, but can be combined with the second chemical composition. Leoncavallo discloses such a dispenser in U.S. Patent No. 6,305,576. The reference teaches a dispenser providing a first container (10) with a first chemical composition in a first compartment and a second container (30) with a second chemical composition in a second compartment in said first container, wherein the first container has an openable closure member (16/28) comprising a spout (18) having an opened position and a closed position (Figure 3 in which Figure 1 would operate in the same fashion), whereby the first chemical composition is maintained apart from said second chemical composition when the openable closure member (16/28) is closed, but can be combined with the second chemical composition when the closure member (16/28) is opened (Figure 1; column 3, line 62 to column 4, line 64), wherein the second container is positioned inside as well as integral to the first container (concerning claims 2 and 3) in order to provide added convenience and environmental benefits as disclosed in column 1, lines 33-45. See Figure 1 and column 3, line 62 to column 4, line 64.
The integral container of Leoncavallo is used for containing toxic chemical compositions that are utilized for laboratory, scientific or medical uses (column 1, lines 15-28). Thus, it would have been obvious to one of ordinary skill in the art at the time of the invention to employ the container of Leoncavallo in the method of Vellutato, since the method of Vellutato achieves sterilization of medical and chemical compositions, wherein said compositions may be safely contained by the integral container of Leoncavallo. Indeed, one would have expected success when applying the method of Vellutato to containers such as that disclosed by Leoncavallo.
Vellutato in view of Leoncavallo does not appear to disclose that the first chemical composition comprises a diluent and the second composition comprises a disinfectant liquid comprising phenol. However, it is conventionally known in the art of sterilization to prepare a sterilizing solution by mixing a diluent with a disinfecting liquid comprising phenol. Carpenter discloses an example of this in U.S. Patent No. 6,150,423. The reference discloses the preparation of a sterilizing solution wherein the first chemical composition comprises a diluent and the second chemical composition comprises a disinfecting liquid comprising phenol (column 2, lines 40-50). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to utilize a diluent as the first chemical composition and a disinfecting liquid comprising phenol as the second chemical composition in the method of Vellutato in view of Leoncavallo, as such are conventionally known and commonly used chemical compositions in the art of sterilization as exemplified by Carpenter. Furthermore, said solution is provided with a shelf life. In order to extend that shelf life, it would have been obvious to one of ordinary skill to separate the solution in the first and second containers of Vellutato in view of Leoncavallo so that the first container comprises the diluent and the second container comprises the disinfectant comprising phenol.
Regarding claims 7, 8 and 20, Vellutato continues to disclose that the irradiating step comprises subjecting the closed shipping package to gamma radiation in the range of about 20 to 50 kilograys in a plurality of directions (column 5, lines 13-34).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-3, 6-8, 16, 19 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-46 of U.S. Patent No. 10,729,795 (herein referred to as ‘795).
Although the claims at issue are not identical, they are not patentably distinct from each other because all of the limitations of claims 1-8 and 16-20 are met by claims 1-46 of ‘795. More specifically, each are directed to a method of sterilizing a chemical composition by providing a first container comprising an openable closure member with a spout having an opened position and a closed position; wherein the first container includes a first chemical composition comprising a diluent. Each further claim a second container with a second chemical composition comprising a disinfectant liquid, and that the first container is positioned with respect to the second container so that the first chemical composition is maintained apart from said second chemical composition, but can be combined with the second chemical composition. Furthermore, each claim that the first and second containers are sealed in in a first sealing layer to form a first sealed container enclosure, and said first sealed container enclosure is enclosed in a shipping container to form a closed shipping package. The closed shipping package is externally irradiated at a predetermined radiation level for a predetermined time interval to simultaneously sterilize said first and second chemical compositions, said first and second containers, said first sealed container enclosure, and said closed shipping package.
As such, the obviousness type double patenting rejection exists.
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.
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/KEVIN JOYNER/Primary Examiner, Art Unit 1799