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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/16/2026 has been entered.
Response to Amendment
3. This is an office action in response to Applicant's arguments and remarks filed on 04/16/2026. Claims 17-18, 21-22, 25, and 31-34 are pending in the application and 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 All rejections from the previous office action are withdrawn in view of Applicant's amendment.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.6-11 of the amendment, the Applicant argues that Ricciardi (alone, or in combination) fails to teach the amended 17 claim limitations regarding the humidifier.
Applicant’s arguments with respect to the rejection(s) of claim(s) 17 under 35 USC 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 Therefore, the rejection has been withdrawn.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 Davis et al. (US 20200316239 A1), further in view of Ricciardi (US 8062590 B1).
Claim Rejections - 35 USC § 112
6. 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.
7. Claims 31-32 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 31 recites “wherein the predetermined humidity is a predetermined specific humidity”. It is unclear as to what the metes and bounds of this limitation is, because “specific” is already implied with the term “predetermined”.
Claim 32 is rejected on a dependency basis from claim 31.
8. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
9. Claim 31 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 31 recites “wherein the predetermined humidity is a predetermined specific humidity”. It fails to further limit the claim because “specific” is already implied with the term “predetermined” (i.e., “predetermined humidity is a predetermined humidity”).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
10. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
11. Claims 17-18, 21, 25, and 31-34 are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (US 20200316239 A1), further in view of Ricciardi et al. (US 8062590 B1, cited in prior office action).
Regarding claim 17, Davis teaches an apparatus for sterilizing a medical instrument (20, Fig. 1), including:
a chamber (sterilization chamber, not shown in Fig. 1, [0064]) arranged for placing the medical instrument (endoscope 60, Fig. 1) therein;
a sterilizing agent source (plasma generator 50, Fig. 1) arranged for providing a sterilizing agent (line 52 delivering sterilizing gas, Fig. 1) including at least partially recombined ionized humidified air comprising reactive oxygen and/or nitrogen species ([0006]), the sterilizing agent source being a plasma source (plasma generator 50, Fig. 1),
the plasma source having an input port (end section of line 40, Fig. 1) for feeding a humidified air stream into the plasma source ([0063]), the plasma source being configured to at least partially ionize the humidified air stream (“a source of a sterilizing gas precursor comprising water vapor, oxygen, and nitrogen, configured to provide a flow of the sterilizing gas precursor through the plasma generator between the electrode and the shield to form a plasma”, [0005]), and the plasma source having an output port (outlet of plasma generator 50 connected to line 52, Fig. 1) for feeding an ionized humidified air stream to the chamber (sterilization chamber, not shown in Fig. 1, [0064]) while allowing the ionized humidified air stream to at least partially recombine to form the at least partially recombined ionized humidified air (the partial recombination of the ionized humidified air stream is an downstream intrinsic result of the structural limitations of generating a plasma from a humidified air source, and the existence of a conduit/line 52 downstream of the plasma generator 50 means it is fully capable of allowing the ionized humidified air stream to at least partially recombine, Fig. 1);
a humidifier (32, Fig. 1) connected to the input port of the plasma source (line 40, Fig. 1) for feeding the humidified air stream into the plasma source (plasma generator 50, Fig. 1), wherein the humidifier is configured to control the water content of the air ([0062]) such that the humidified air stream, at an exit of the humidifier, has a predetermined humidity (humidity detector 36 utilizes feedback mechanism to humidification device 32 via control line 38, Fig. 1 and [0062]).
Davis fails to teach a temperature control unit arranged for controlling the temperature of the medical instrument and/or the chamber such that the temperature of the medical instrument is below the temperature of the chamber for allowing the sterilizing agent to at least partially condense onto the instrument.
Ricciardi teaches another medical instrument sterilization chamber system (Fig. 3-4) having an applied agent generator (15, Fig. 3-4) able to utilize plasma, vapor, or aerosol as the sterilizing agent (applied agent 20, Fig. 3 and see col. 6, lines 52-55), further teaching a temperature control unit arranged for controlling the temperature of the medical instrument (cooling system 76, Fig. 20) and a temperature control unit for the chamber (heating plate 32, Fig. 6) such that the temperature of the medical instrument is below the temperature of the chamber (see col. 15, line 64 to col. 16, line 20 for cooling the instrument relative to the chamber, and see col. 23, line 66 to col. 24, line 12 for introducing thermal energy for the applied agent to be more effective) in order to each contribute to the efficacy of the collection of the applied agent to the medical instrument (col. 43, lines 53-54 and col. 24, lines 7-10).
Davis and Ricciardi are both considered to be analogous to the claimed invention because they are in the same field of sterilization chambers for medical instruments utilizing plasma/vapor.
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 chamber of Davis by incorporating a cooling system to cool the medical instrument to be sterilized and a heating plate on a wall of the sterilization chamber to heat the chamber wall as taught by Ricciardi because in doing so would each contribute to the efficacy of the collection of the applied agent to the medical instrument (col. 43, lines 53-54 and col. 24, lines 7-10), and by extension, “allowing the sterilizing agent to at least partially condense onto the instrument” (instant claim 1 limitation).
Regarding claim 18, the Davis/Ricciardi combination teaches wherein the temperature control unit includes a cooling unit arranged for cooling or maintaining the medical instrument below the temperature of the chamber (Ricciardi, cooling system 76, Fig. 20).
Regarding claim 21, the Davis/Ricciardi combination teaches wherein the temperature control unit includes a heating unit arranged for heating or maintaining the wall of the chamber above the temperature of the medical instrument (heating plate 32, Fig. 6), but not the walls of the chamber.
However, it would have been obvious to one of ordinary skill in the art to apply the heating plates on not just one wall of the chamber, but to a plurality, or all of the walls of the chamber, because doing so would predictably increase the thermal energy of applied agent coming close or touching said walls and consequently increasing the efficacy of the collection process (col. 23, line 66 to col. 24, line 12), where “mere duplication of parts has no patentable significance unless a new and unexpected result is produced” (MPEP 2104.44.VI.B).
Regarding claim 25, the Davis/Ricciardi combination teaches wherein the cooling unit (Ricciardi, cooling unit 76, Fig. 20) includes a gas conduit for cooling the medical instrument using a gas (pipes 78 and 79 connected to cooling system 76, Fig. 20).
Regarding claim 31, modified Davis teaches wherein the predetermined humidity is a predetermined specific humidity ([0062]).
Regarding claim 32, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select an absolute humidity value of 12 g/m3 for the humidification device of modified Davis, because in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists (MPEP 2144.05).
Thus modified Davis teaches wherein the predetermined specific humidity of the air entering the plasma source is in the range between 9 g/kg (grams of water per kg of air) and 11 g/kg (e.g., 10 g/kg specific humidity ≈ 12.05 g/m3 in absolute humidity).
Regarding claim 33, modified Davis teaches wherein the humidifier (32, Fig. 1) is configured to add or remove water from the air (“The sterilizing gas precursor is then transported via line 30 to a humidification device 32 to bring the humidity of the sterilizing gas precursor to”, [0062]) such that the humidified air stream, at the exit of the humidifier, has the predetermined humidity (selected absolute humidity value of 12 g/m3 as shown in claim 32 rejection above).
Regarding claim 34, modified Davis teaches wherein the ionized humidified air stream at least partially recombines during transport from the plasma source to the chamber (the partial recombination of the ionized humidified air stream is an downstream intrinsic result of the structural limitations of generating a plasma from a humidified air source, and the existence of a conduit/line 52 downstream of the plasma generator 50 means it is fully capable of allowing the ionized humidified air stream to at least partially recombine, Fig. 1) and before the sterilizing agent contacts the medical instrument (already implied with “during transport from the plasma source to the chamber” limitation).
12. Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (US 20200316239 A1), further in view of Ricciardi et al. (US 8062590 B1), as applied to claim 18 above, further in view of Martens et al. (US 5603895 A).
Regarding claim 22, the Davis/Ricciardi combination teaches the sterilization chamber (Davis, not shown in Fig. 1, [0064]) having a medical instrument placed therein (Davis, endoscope 60, Fig. 1), and in fluid connection to a cooling system (Ricciardi, 76, Fig. 20) but fails to teach a container arranged for receiving the medical instrument, and arranged for being placed in the chamber, wherein the cooling unit is arranged for cooling the container to below the temperature of the chamber.
Martens teaches a plasma water vapor sterilization system (Fig. 5) having a plasma generator (12’, Fig. 5) in fluid communication with a water vapor source (“a source of water vapor in fluid communication with the plasma generator”, abstract), where the object to be sterilized are placed in baskets (116’, Fig. 5) in order to “permit the activated gas to reach all surfaces of the articles” (col.9, lines 21-22).
The Davis/Ricciardi combination and Martens are both considered to be analogous to the claimed invention because they are in the same field of plasma water vapor sterilization chambers.
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 chamber holding the object to be sterilized (i.e., endoscope) of the Davis/Ricciardi combination by incorporating a wire basket container for the object to be sterilized is placed in as taught by Martens because in doing so would “permit the activated gas to reach all surfaces of the articles” (Martens, col.9, lines 21-22).
In view of this modification, the Davis/Ricciardi/Martens combination would teach wherein the cooling unit is arranged for cooling the container to below the temperature of the chamber, because Ricciardi’s cooling unit cools the object to be sterilized (“comprises cooling or decreasing the temperature of the objects… including the internal surfaces of an object(s) such as, but not limited to an endoscope, within the sterilization chamber(s)”, col.15, line 65 to col.16, line 2), which now includes the wire basket of Martens as well.
Conclusion
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
