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 .
Response to Amendment
2. This is an office action in response to Applicant's arguments and remarks filed on 03/30/2026. Claims 1, 3-4, 6, 8, 10-12, 14-17, and 19-22 are pending in the application. Claims 8, 10-12, and 15-16 have been withdrawn and claims 1, 3-4, 6, 14, 17, and 19-22 are being examined herein.
Status of Objections and Rejections
3. All rejections from the previous office action are withdrawn in view of Applicant's amendment.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
4. In the arguments presented on p.5-7 of the amendment, the Applicant argues that primary reference Yamamoto fails to teach the amended limitations of claim 1.
Applicant’s arguments with respect to the rejection(s) of claim(s) 1 under 35 USC 102(a)(1) 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 Therefore, the rejection has been withdrawn.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 Yamamoto et al. (US 20030049165 A1, cited in prior office action).
In the arguments presented on p.8-10 of the amendment, the Applicant argues that each secondary reference utilized in each of its respective dependent claim rejections fail to teach specific limitations.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Claim Rejections - 35 USC § 112
5. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
6. Claims 4, 6, and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites “at least one support member” in line 2 and line 3. There is insufficient antecedent basis for this limitation in the claim.
Claims 4 and 6 depend on claim 2, which was canceled. For compact prosecution purposes, claims 4 and 6 will be interpreted as if it depends from claim 1.
Claim 14 recites “at least one support member” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
7. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
8. Claims 1, 3-4, 6, 14, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto et al. (US 20030049165 A1).
Regarding claim 1, Yamamoto teaches a device for retaining an object (sterilization basket holding a sterilization bag 21, [0045]) in a disinfection apparatus (Fig. 1), said device including:
a support member (basket/porous container, [0023]), for direct contact engagement with one or more contact surfaces of said object (object is sterilization bag that is placed within basket that directly contacts the sterilization basket, [0061]),
wherein said support member is formed from a material (basket can comprise thermoplastic resin, [0092]) that allows a disinfection fluid to reach said one or more contact surfaces of said object (sterilization agent of gaseous hydrogen peroxide penetrates through pores in the porous container comprising thermoplastic resin, [0092]) such that said one or more contact surfaces are disinfected during a disinfection process (the sterilization bag object being housed/placed within the porous container would mean said contact surfaces are disinfected during a disinfection cycle because the outer and inner bags are both hydrogen peroxide permeable, [0089]).
The limitation of “allows a misted disinfection fluid to reach said one or more contact surfaces of said object”, is directed to the or the manner of operating the apparatus. All the structural limitations of the claim has been disclosed by Yamamoto and the sterilization basket in the sterilization device of Yamamoto is capable of allowing a misted disinfection fluid to reach said contact surfaces. 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, Yamamoto teaches a porous container responsible for allowing gaseous hydrogen peroxide to reach said contact surfaces ([0054] and [0089]), where “gaseous” includes the options of “hydrogen peroxide vapor, a hydrogen peroxide-containing gas or an aerosol of hydrogen peroxide prepared by, for instance, atomization of a hydrogen peroxide solution”; an aerosol via atomization of a hydrogen peroxide is a misted version of the hydrogen peroxide as a sterilant.
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.
Yamamoto teaches wherein the basket/porous container can be made of thermoplastic resin ([0092]), but fails to teach wherein said support member is formed from a material that comprises PET (polyester), Polypropylene and/or Nylon.
However, Yamamoto lists out examples of thermoplastic resins in its thermoplastic elastomer definition paragraph ([0075]), specifically citing polypropylene resin as an option.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select a polypropylene resin as the thermoplastic resin material comprising the basket/porous container as taught by Yamamoto in order to predictably “stand the weight of the mounted article” even when “exposed to a hydrogen peroxide gas for a long time” ([0092]).
Regarding claim 3, modified Yamamoto teaches wherein said disinfection fluid includes hydrogen peroxide (hydrogen peroxide supply 6, Fig. 1 and [0001]).
Regarding claim 4, modified Yamamoto teaches wherein said at least one support member is formed from a fluid permeable material (basket/porous container has pores that allow the gaseous hydrogen peroxide to permeate through, [0089]) such that the disinfection fluid is able to travel through said at least one support member to reach the one or more contact surfaces during said disinfection process (“a gaseous sterilization agent penetrates from an upper opening of the outer bag through a bottom and a side wall of the container”, [0089]).
Regarding claim 6, modified Yamamoto teaches wherein said disinfection fluid travels along the surface of said at least one support member (gaseous hydrogen peroxide travels along the surfaces of the porous container in order to permeate through and reach the outer bag sterilization object) to reach said one or more contact surfaces during said disinfection process (“a gaseous sterilization agent penetrates from an upper opening of the outer bag through a bottom and a side wall of the container”, [0089]).
Regarding claim 14, modified Yamamoto teaches wherein said at least one support member comprises a basket for carrying the object during the disinfection process (porous container is a basket, [0089]).
Regarding claim 19, modified Yamamoto teaches wherein said disinfection apparatus includes an enclosed chamber (sterilization chamber 2, Fig. 1), and wherein said device for retaining an object is adapted to suspend said object within said chamber during said disinfection process (“They may be treated in a box-like or bath-shaped sterilization chamber, while they are randomly accommodated in sterilization bags and the resulting bulk materials are placed or suspended in the chamber”, [0115]).
9. Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto et al. (US 20030049165 A1) as applied to claim 1 above, and further in view of Zhou (CN 208259940 U, cited in prior office action).
Regarding claim 17, modified Yamamoto teaches the suspension of the sterilization basket within the chamber (“They may be treated in a box-like or bath-shaped sterilization chamber, while they are randomly accommodated in sterilization bags and the resulting bulk materials are placed or suspended in the chamber”, [0115]), 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 Yamamoto 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 sterilization basket/bag assembly containing the article to be sterilized during sterilization of modified Yamamoto 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 rotating the mechanical arm to subject the basket to the sterilizing fluid (Zhou, p.3, last paragraph of English translation).
10. Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto et al. (US 20030049165 A1) 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 Yamamoto teaches a specific injection amount of hydrogen peroxide ([0017]), where there is a sufficient/predetermined level of sterilant that is injected through a series of pulses ([0127]), 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.
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 Yamamoto 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 sterilization bag/basket assembly of modified Yamamoto 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 Yamamoto teaches a specific injection amount of hydrogen peroxide ([0017]), where there is a sufficient/predetermined level of sterilant that is injected through a series of pulses ([0127]), 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 Yamamoto 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 sterilization bag/basket assembly of modified Yamamoto 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 Yamamoto 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.
11. Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto et al. (US 20030049165 A1) 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 Yamamoto teaches the sterilization of articles such as “a sealing tool, a container, a joint, a cap or a plunger” ([0064]), 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 Yamamoto 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 articles to be sterilized of modified Yamamoto by incorporating an option such as an ultrasound/medical probe in order to “disinfect and sterilize the surface of the medical probe and air around the medical probe” (Kim, abstract).
Conclusion
12. 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.
13. 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.
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, 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.
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.
/Aham Lee/Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
Prosecution Insights