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 .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 –
(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.
Claims 11-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Farb (WO 2021/195017).
Regarding claim 11, Farb (WO 2021/195017) discloses –
A system for disinfecting epithelium of a living organism (abstract, a living human tissue is treated), the system comprising:
a device having a surface configured for being placed in proximity to the epithelium of the living organism (Fig. 3, tubing 307 administers an iodine formulation, p. 6 par. 8); and
a container in contact with the device, the container containing sterilized iodine and being pressurized to a positive pressure (Fig. 3 reserve container 305 and vaporization container 306, p. 6 par. 8; the container contains heated and vaporized sterile iodine that is pressurized for administration),
the container being configured to release the sterilized iodine under the positive pressure to disinfect the surface of the device prior to or while the surface is placed in proximity to the epithelium of the living organism to disinfect the epithelium in proximity thereof (p. 11 par. 3 disclose a positive pressure being applied by a ventilator for administration of iodine treatment, the iodine vapor would reasonably also disinfect the surface of the device during an application step).
Regarding claims 12-17, the claimed invention is directed towards a device or apparatus, and the method of making the sterilized iodine that in a post-production state is intended to be used in conjunction with the device does not patentably distinguish the claimed apparatus from the prior art, because he patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See MPEP 2113, I. All of the structural limitations of the system are disclosed and the system is well capable of producing iodine in the claimed manner, and therefore all the limitations of the claims are met.
Further regarding claim 12, Farb further teaches sterilized iodine is produced by: providing an iodine antiseptic solution to the container (p. 6 par. 8 discloses the reserve container containing the iodine); and during a sterilization cycle:
heating the iodine antiseptic solution in the container to a sterilization temperature sufficient to generate free elemental iodine in the container (the iodine is vaporized by heating resulting in free elemental iodine, p. 7 par. 2); and applying a positive pressure in the container to pressurize the free elemental iodine to produce the sterilized iodine within the container (p. 7 par. 2, the ventilator administers the vapor by applying pressure to pump the solution to a patient).
Regarding claim 13, Farb further teaches the sterilization temperature is between about 60°C to about 100°C (p. 10 last 3 pars. disclose heating to 65-80 degrees centigrade).
Regarding claim 14, Farb further teaches the sterilization temperature is between about 70°C to about 80°C (p. 10 last 3 pars. disclose heating to 65-80 degrees centigrade).
Regarding claim 15, Farb discloses all of the structural features of the systems as set forth above, and this manner in which the sterilized iodine is produced does not distinguish the claimed device from the prior art.
Regarding claim 16, Farb further teaches the sterilization time cycle is between about 3 minutes to about 24 hours (p. 7 last par. disclose the treatment takes place over the course of 10 minutes).
Regarding claim 17, Farb further teaches the sterilization time cycle is between about 10 minutes and about 30 minutes (p. 7 last par. disclose the treatment takes place over the course of 10 minutes).
Response to Arguments
Applicant's arguments filed 5/18/26 have been fully considered but they are not persuasive.
Applicant’s arguments directed towards claim 11 arguing Farb fails to teach the “self-sterilization of an iodine-containing solution within a closed container” are not persuasive. Claim 11 requires a system for disinfecting epithelium of a living organism (see the preamble of the claim), the system including a device with a surface, a closed container already containing sterilized iodine, and the container being configured to release the sterilized iodine. The system has no structure and requires no function therefrom that could or is required by the claim to “self-steriliz[e] … an iodine-containing solution”. Applicant’s arguments are directed toward features and functions that are not present in the claim and are therefore not persuasive.
Applicant’s remarks on pages 7-8 further arguing the properties of the iodine antiseptic solution are not taught by Farb are further not persuasive because the claimed invention directed towards a system for disinfecting epithelium of a living organism do not require an iodine antiseptic solution, and the manner in which the sterilized iodine is made does not patentably distinguish the claimed apparatus from the prior art where all the structure of the prior art is taught, see MPEP 2113, I.
Applicant’s remarks on page 8 arguing Farb fails to teach a positive pressure and a closed system are further not persuasive. The device only dispenses after actuation of a valve by an actuator and itself comprises a container 305 that and 306 that reads on the limitation of “closed”. The container performs the function of persistently retaining a warmed solution and only dispenses selectively, and therefore the container includes a closed one that is at a positive pressure, because a warmed solution exists at an elevated pressure unless some volume is expanded as vapor is produced, and the container must be closed in order to contain the warmed solution.
Applicant further argues on page 8 the claimed invention teaches sterilization which cannot be the case in claim 11 because the claim is directed towards a “system for disinfecting”, where Farb also teaches that very same type of system.
Applicant’s remarks on pages 8-9 arguing Farb fails to teach a container pressurized to a positive pressure and releasing the sterilized iodine to disinfect the surface are further not persuasive because the warming of a solution in a closed container to 80 degrees Celsius and the application of pressure to distribute the formed vapor reads on the claimed limitation of a container that is pressurized to a positive pressure and the subsequent release of iodine vapor which is recognized by both the present disclosure and the prior art as being disinfecting agent would necessarily perform the function of providing some disinfecting to the surfaces of the device such as the tubing 307 that the vapor comes into contact with, irrespective to the teaching of Farb that also sets forth the disinfection of tissue which is once again required in the preamble of claim 11.
Applicant’s remarks on page 10-11 arguing the self-sterilizing method and operating parameters are not taught by Farb are further not persuasive. The claim is directed towards an apparatus and does not anywhere in any claim positively recite the presence of “iodine antiseptic solution” and therefore the manner in which the sterilized iodine is produced is merely an intended use of the apparatus or at best a recitation of a process step in a product-by-process-type claim, which is not a structure feature of the apparatus claim and cannot distinguish the claimed invention from the prior art. See MPEP 2114, II and MPEP 2113, I.
Applicant argues that the product produced is different which is not persuasive because the product as claimed, in this case a sterilized iodine solution, is not different from the iodine solution that is taught by Farb. The claimed sterilized iodine solution does not require the pH nor the ppm that Applicant argues on page 10.
Similarly, Applicant’s arguments on page 11 are not persuasive because these process steps do not modify any component that is positively claimed as being part of the claimed apparatus and are therefore not structural features of the apparatus. The limitations are an intended use of the apparatus or at best a recitation of a process step in a product-by-process-type claim, which is not a structure feature of the apparatus claim and cannot distinguish the claimed invention from the prior art. See MPEP 2114, II and MPEP 2113, I.
Applicant’s remarks on pages 11-12 summarizing the alleged differences between the prior art and the claimed invention are not persuasive as they do not accurately characterize the recited structural requirements of the claimed apparatus, nor do they reasonably address the teachings of the prior art in the manner in which they are relied upon in the rejection above.
The claims remain rejected.
Conclusion
THIS ACTION IS MADE FINAL. 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 BRENDAN A HENSEL whose telephone number is (571)272-6615. The examiner can normally be reached Mon-Thu 8:30 - 7pm;.
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/BRENDAN A HENSEL/Examiner, Art Unit 1758
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