DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/17/2026 has been entered.
Response to Amendment
3. This is an office action in response to Applicant's arguments and remarks filed on 07/17/2026. Claims 1, 3-4, 6, 8, 10-12, 14-17, and 20-22 are pending in the application. Claims 8, 10-12, and 15-16 have been withdrawn and claims 1, 3-4, 6, 14, 17, and 20-22 are being examined herein.
Status of Objections and Rejections
4. All rejections from the previous office action are withdrawn in view of Applicant's amendment.
New grounds of rejection under 35 U.S.C. 103 are necessitated by the amendments.
Response to Arguments
5. In the arguments presented on p.6-9 of the amendment, the Applicant argues that Yamamoto does not teach the amended claim 1 limitations (and by extension, the Zhou secondary reference in the claim 17 rejection) and there would be no motivation to modify Yamamoto to reach said amended limitations.
Applicant’s arguments with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Malchesky (US 6558622 B1), further in view of POREX (cited in PTO-892 form).
The Examiner would like to address that the wicking functionality argument in p.6 of the amendment (while important to the instant invention) does not persuade the Examiner to give the instant claim 1 limitation a positive recitation as Applicant intends – amended claim 1 recites “a wickable material configured to transport a misted disinfection fluid to reach said one or more contact
surfaces of said object through wicking such that said one or more contact surfaces are
disinfected during a disinfection process”, to which as long as the “wickable material” is functionally capable of transporting a misted disinfection fluid through wicking to the target object’s surface, it would read on this limitation. The distinction between a vaporized hydrogen peroxide sterilization cycle and Applicant’s misted disinfection cycle does not matter if the wickable material in the art is functionally capable of wicking.
Claim Rejections - 35 USC § 103
6. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
7. Claims 1, 3-4, 6, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Malchesky (US 6558622 B1), further in view of POREX (“POREX POROUS POLYMERS”, [https://web.archive.org/web/20191122000045/https://www.interstatesp.com/materials/porex/], cited in PTO-892 form).
Regarding claim 1, Malchesky teaches a device (support system 80, Fig. 2) for retaining an object in a disinfection apparatus having an enclosed chamber (10, Fig. 2), said device including:
a support member for direct contact engagement with one or more contact surfaces of said object to suspend said object within said enclosed chamber of said disinfection apparatus (support system 80 of Fig. 2 comprising a mesh basket with a rigid, open-celled porous media from POREX, col.6, last paragraph).
Malchesky, while teaching a rigid, open-celled porous media from POREX to hold the objects and allow disinfection fluid to permeate through (col.6, last paragraph), does not explicitly mention wherein said support member is formed from a wickable material configured to transport a misted disinfection fluid to reach said one or more contact surfaces of said object through wicking such that said one or more contact surfaces are disinfected during a disinfection process, wherein said material comprises PET (polyester), Polypropylene and/or Nylon. Malchesky merely provides a general structure as to what is supporting the object, not its specific material properties. One of ordinary skill would look to POREX’s rigid, open-celled porous media options.
POREX’s website, before the effective filing date of the instant Application, mentions that its rigid, open-celled porous media not only allow for diffusion, but the added functionality of wicking as well, the porous media comprising sintered polypropylene as an option (p.2-3).
Malchesky and POREX are both considered to be analogous to the claimed invention because they are in the same field of rigid, open-celled porous media for its diffusion capabilities.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the rigid, open-celled support in direct contact to the target object of Malchesky by selecting a sintered polypropylene open-celled porous medium as the material, because doing so would not only allow for permeability/diffusion, but also the benefit of wicking (POREX, p.2-3) with a reasonable expectation of success.
The limitation of “configured to transport a misted disinfection fluid to reach said one or more contact surfaces of said object through wicking such that said one or more contact surfaces are disinfected during a disinfection process” is directed to the function of the apparatus and/or the manner of operating the apparatus. All the structural limitations of the claim has been disclosed by modified Malchesky and the apparatus of modified Malchesky is capable of wicking a misted disinfection fluid to a target object surface during a disinfection process. As such, it is deemed that the claimed apparatus is not differentiated from the applicant' s invention (see MPEP §2114).
NOTE: this is a recitation of intended use / functional language, and so long as the prior art structure reads on the instant claimed structure, this limitation would be met because the same structure would be capable of the same function; in this case, POREX’s media has a wicking functionality, and because the media is in direct contact with the object to be disinfected (Malchesky, col.6, last paragraph), the media is fully capable of wicking a disinfection fluid to the target object surface.
Per MPEP 2114,II, claims cover what a device is, not what a device does. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim.
Regarding claim 3, modified Malchesky teaches wherein said disinfection fluid includes hydrogen peroxide (hydrogen peroxide supply 16, Fig. 1).
Regarding claim 4, modified Malchesky teaches wherein said support member is formed from a fluid permeable material such that the disinfection fluid is able to travel through said support member to reach the one or more contact surfaces during said disinfection process (“permitting the antimicrobial fluid and the cleaning fluid to penetrate to the surfaces of the instruments”, col.6, last paragraph)
Regarding claim 6, modified Malchesky teaches wherein said disinfection fluid travels along the surface of said support member to reach said one or more contact surfaces during said disinfection process (the hydrogen peroxide antimicrobial fluid supplied by inlet 30 is within the entire chamber 10, including the surface of support system 80 that reaches the target object, Fig. 1).
Regarding claim 14, modified Malchesky teaches wherein said at least one support member comprises a basket for carrying the object during the disinfection process (mesh basket as part of support system 80, Fig. 2).
8. Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Malchesky (US 6558622 B1), further in view of POREX, as applied to claim 1 above, and further in view of Zhou (CN 208259940 U, cited in prior office action).
Regarding claim 17, modified Malchesky teaches the suspension of the sterilization mesh basket within the chamber (support system 80, Fig. 2), but fails to specifically recite the exact structure that performs the suspending, much less an elongate hanger.
Zhou teaches a medical instrument sterilizer (Fig. 1-2) utilizing hydrogen peroxide (“the currently used medical disinfectant comprises hydrogen peroxide”, p.2, 1st paragraph of English translation) having a hanging basket (4, Fig. 1) containing the medical device (p.2, 3rd paragraph of English translation), where the hanging basket is connected to a hanger on an elongated rotary mechanical arm (3, Fig. 1) in order to hook the hanging basket and rotating the mechanical arm to subject the basket to the sterilizing fluid (p.3, last paragraph of English translation).
Modified Malchesky and Zhou are both considered to be analogous to the claimed invention because they are in the same field of suspended baskets in hydrogen peroxide sterilization systems.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the suspension of the mesh basket containing the article to be sterilized during sterilization of modified Malchesky by incorporating a suspension structure means such as an elongated rotary arm hanger as taught by Zhou in order to hook the hanging basket and rotate the mechanical arm to subject the basket to the sterilizing fluid (Zhou, p.3, last paragraph of English translation), providing an “enhancing sterilizing effect” (Zhou, p.3, last paragraph of English translation).
9. Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Malchesky (US 6558622 B1), further in view of POREX, as applied to claim 1 above, and further in view of Antonoplos et al. (US 5942438 A, cited in prior office action).
Regarding claim 20, modified Malchesky teaches the injection of hydrogen peroxide to cause the killing of microbes on the objects (see claim 18) but fails to teach wherein at least a portion of said device is impregnated with a dye that changes color when exposed to a disinfection fluid for a pre-defined period or a pre-defined temperature for a pre-defined period.
Antonoplos teaches an indicator comprising a bleachable dye (abstract), where when the indicator is placed in the chamber with the medical instruments to be sterilized (col. 1, lines 34-35), to which when the indicator is exposed to an oxidant such as hydrogen peroxide “for an appropriate amount of time the bleachable dye changes color” (abstract) in order to “provide verification that an adequate amount of sterilant was provided to the chamber” (col. 1, lines 36-37).
Modified Malchesky and Antonoplos are both considered to be analogous to the claimed invention because they are in the same field of sterilization chambers utilizing hydrogen peroxide for articles to be sterilized.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the support system of modified Malchesky by incorporating the placement of a chemical indicator having a dye responsive to hydrogen peroxide exposure for an appropriate amount of time as taught by Antonoplos in order to “provide verification that an adequate amount of sterilant was provided to the chamber” (Antonoplos, col. 1, lines 36-37).
Regarding claim 21, modified Malchesky teaches the injection of hydrogen peroxide to cause the killing of microbes on the objects (see claim 18) but fails to teach wherein at least a portion of said device is impregnated with a dye that changes color when exposed to a disinfection fluid for a pre-defined period or a pre-defined temperature for a pre-defined period.
Antonoplos teaches an indicator comprising a bleachable dye (abstract), where when the indicator is placed in the chamber with the medical instruments to be sterilized (col. 1, lines 34-35), to which when the indicator is exposed to an oxidant such as hydrogen peroxide “for an appropriate amount of time the bleachable dye changes color” (abstract) in order to “provide verification that an adequate amount of sterilant was provided to the chamber” (col. 1, lines 36-37).
Modified Malchesky and Antonoplos are both considered to be analogous to the claimed invention because they are in the same field of sterilization chambers utilizing hydrogen peroxide for articles to be sterilized.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the support system of modified Malchesky by incorporating the placement of a chemical indicator having a dye responsive to hydrogen peroxide exposure for an appropriate amount of time as taught by Antonoplos in order to “provide verification that an adequate amount of sterilant was provided to the chamber” (Antonoplos, col. 1, lines 36-37).
In continuation, modified Malchesky in view of Antonoplos further teaches the chemical indicator being resistant to temperature and humidity up to a certain time. Specifically, “the chemical indicator maintains its original color for at least three months when stored at 23.degree. C. at 50% relative humidity” (Antonoplos, col.10, last paragraph), implying that the dye will change color after the predetermined time of three months at the pre-defined temperature of 23 degrees Celsius.
10. Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Malchesky (US 6558622 B1), further in view of POREX, as applied to claim 1 above, and further in view of Kim et al. (KR 20200009287 A, cited in prior office action).
Regarding claim 22, modified Malchesky teaches the sterilization of medical instruments as the article/object to be sterilized (abstract), but fails to teach wherein the article/object to be disinfected is an ultrasound probe.
Kim teaches an ultrasound probe disinfection apparatus (100, Fig. 1), where the medical/ultrasound probe (P, Fig. 1 and p.2, 3rd paragraph of English translation) is exposed to vaporized hydrogen peroxide “in order to disinfect and sterilize the surface of the medical probe and air around the medical probe” (abstract).
Modified Malchesky and Zhou are both considered to be analogous to the claimed invention because they are in the same field of hydrogen peroxide sterilization chambers for objects/articles to be disinfected.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the selection of medical instruments to be sterilized of modified Malchesky by incorporating an option such as an ultrasound/medical probe in order to predictably “disinfect and sterilize the surface of the medical probe and air around the medical probe” (Kim, abstract).
Conclusion
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Aham Lee whose telephone number is (703)756-5622. The examiner can normally be reached Monday to Thursday, 10:00 AM - 8:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris R. Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Aham Lee/Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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