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 .
Election/Restrictions
2. Applicant’s election without traverse of claims 1-16 in the reply filed on 23 October 2025 is acknowledged. Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 23 October 2025.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on 27 October 2023 and 07 November 2024 are being considered by the examiner.
Claim Interpretation
4. The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
5. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
6. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “sterilization module” in claim 14, interpreted as an atomizer per Specification par 0080 and equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
7. Claim 9 is objected to because of the following informalities: in the second line, “to detect fluid height” should read --to detect a fluid height--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
8. 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.
9. Claims 12-13 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.
10. Regarding claim 12, it is unclear whether the limitation “further configured to initiate driving of the fluid into the dosing cylinder direct driving of the fluid in a pulsatile fashion” is to be construed as a single action (i.e., “further configured to initiate driving of the fluid into the dosing cylinder in a pulsatile fashion) or multiple actions (i.e., further configured to initiate driving of the fluid into the dosing cylinder and direct driving of the fluid in a pulsatile fashion). The grammar is improper leading to an indefinite scope, and the prior art rejection relies on an interpretation as two distinct controller actions.
11. Regarding claim 13, it is unclear whether the limitation “further configured to initiate driving of the fluid into the dosing cylinder direct driving of the fluid in a continuous fashion” is to be construed as a single action (i.e., “further configured to initiate, in a continuous fashion, driving of the fluid into the dosing cylinder) or multiple actions (i.e., further configured to initiate driving of the fluid into the dosing cylinder and direct driving of the fluid in a continuous fashion). The grammar is improper leading to an indefinite scope, and the prior art rejection relies on an interpretation as two distinct controller actions.
Claim Rejections - 35 USC § 103
12. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
13. Claims 1-4, 6-8, and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Goncalves (US 20170312378 A1).
14. Regarding claim 1, Goncalves discloses a system (process and device for sterilization/disinfection, par 0001; FIG. 1a; pars 0107-0110) for measuring chemical components (precision of the drop by drop dosing…of hydrogen peroxide or other chemicals, pars 0008-0009), the system comprising:
a dosing cylinder (tank 6F, FIG. 1a) configured to receive and measure a fluid containing one or more chemical components (chemical product is pumped by the filling pump 7 and placed into a tank 6F, par 0109; level of the chemical product is controlled by the level sensor, par 0110), the dosing cylinder including a fluid sensor (level float 6B/level sensor 6A, par 0110, FIG. 1a);
a pump operably coupled to the dosing cylinder (filling pump 7, FIG. 1a), the pump configured to drive the fluid to the dosing cylinder (chemical product is pumped by the filling pump 7 and placed into a tank 6F, par 0109); and
a controller (computer or control unit, par 0110) in communication with the dosing cylinder and the pump (chemical product tank 6F is provided with a system that controls the float 6B and interacts with the computer or the control unit, par 0110), the controller configured to (computer that controls the process, par 0122):
generate a signal to initiate driving of the fluid into the dosing cylinder (chemical product is pumped by the filling pump 7 and placed into a tank 6F, par 0109; an order from the operator starts the refilling sequence, pars 0107-0108), receive a signal from the fluid sensor in response to the fluid reaching a predetermined volume in the dosing cylinder (level of the chemical product is controlled by the level or pressure sensor 6A which sends the information to the computer, par 0110),
and dispersing the fluid from the dosing cylinder to a sterilization system (small vapor quantities of the mixture from the vaporizer chamber to the sterilization/disinfection chamber 1, pars 0111-0113) in a dose of the predetermined volume (adjustable dose system allows the adjustment of a defined dose of a certain chemical product, par 0111).
Goncalves does not explicitly teach that tank 6F, which is configured to receive and measure doses to perform the functions of the claimed dosing cylinder, is a cylinder. As many fluid containment vessels are known to take the form of a cylinder (including bottle/container 8F of Goncalves, FIGS. 1a-b), making such a tank cylindrical would be a matter of obvious design choice absent persuasive evidence that the particular configuration is significant. See MPEP 2144.04(IV)(B), in re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Goncalves also does not explicitly teach that the controller would generate a signal to stop pumping of the fluid into the dosing cylinder, though it is known that the filling pump 7 fills the tank 6F as a finite action (pars 0107 and 0109) and the level in the tank 6F is controlled by the level sensor 6A (par 0110). In the next sequence of the process, the same controller does send a signal to stop the dosing peristaltic pump 5 after a circulation period (par 0111), teaching a dosing period started by a start signal and stopped by a stop signal.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the controller of Goncalves to generate a signal to stop pumping of the fluid into the dosing cylinder, as Goncalves teaches that the controller can send a stop signal to predictably and reliably control the dosing provided by a pump. It would further have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the tank 6F of Goncalves as a cylinder, as such a shape would predictably hold a controllable amount of liquid for distribution into the sterilization system.
15. Regarding claim 2, Goncalves teaches the system of claim 1, wherein dispersing the fluid from the dosing cylinder to the sterilization system is in response to an indication of a desired amount of sterilant filling the dosing cylinder (level of the chemical product is controlled by the level sensor which sends the information to the computer, par 0110; computer system gives indication to the dosing peristaltic pump 5 to start pumping the chemical product from tank 6F, par 0111).
16. Regarding claim 3, Goncalves teaches the system of claim 2, further comprising a second pump operably coupled to the dosing cylinder (FIG. 1a, dosing pump 5 removes chemical product from tank 6F, par 0110), the second pump for driving the fluid from the dosing cylinder to the sterilization system for a sterilization cycle (liquid fed to vaporizer by dosing peristaltic pump 5 to dose small quantities to the sterilization/disinfection chamber, pars 0111-0113).
17. Regarding claim 4, Goncalves teaches the system of claim 1, further comprising a fluid source (FIG. 1a, bottle/container 8F of supply system 8, pars 0106-0109) coupled to the pump (after the perforation of the bottle/container, the chemical product is pumped by the filling pump 7, par 0109).
18. Regarding claim 6, Goncalves teaches the system of claim 1, further comprising a sterilization system fluidly coupled to the dosing cylinder (FIG. 1a, sterilization/disinfection chamber 1 connected via vaporizer/mixer 4 and dosing pump 5 to tank 6F, par 0110), wherein the sterilization system is configured to receive the predetermined volume of fluid for a sterilization cycle (defined dose of a certain chemical product…introduced drop by drop into the vaporizer/mixer, par 0111; dose small vapor quantities of the mixture/combination from the vaporizer chamber 4G to the sterilization/disinfection chamber, par 0113).
19. Regarding claim 7, Goncalves teaches the system of claim 6, further comprising a valve between the dosing cylinder and the sterilization system (FIG. 1a, three way vaporization valves 4E, par 0110) for regulating flow of the fluid between the dosing cylinder and the sterilization system (it introduces the chemical product into one of the vaporizer's/mixer's capillary tubes…then diffused to the sterilization/disinfection chamber, par 0110).
20. Regarding claim 8, Goncalves teaches the system of claim 6, further comprising a second pump between the dosing cylinder and the sterilization system (FIG. 1a, dosing pump 5 removes chemical product from tank 6F, par 0110), the second pump for driving the fluid into the sterilization system from the dosing cylinder (liquid fed to vaporizer by dosing peristaltic pump 5 to dose small quantities to the sterilization/disinfection chamber, pars 0111-0113).
21. Regarding claim 12, Goncalves teaches the system of claim 1, wherein the controller is further configured to initiate driving of the fluid into the dosing cylinder (after e.g., RFID verification by controller, chemical product is pumped by the filling pump 7 and placed into a tank 6F, pars 0108-0109) and to direct driving of the fluid in a pulsatile fashion (pulsing controlled by the computer system, par 0111).
22. Regarding claim 13, Goncalves teaches the system of claim 1, wherein the controller is further configured to initiate driving of the fluid into the dosing cylinder (after e.g., RFID verification by controller, chemical product is pumped by the filling pump 7 and placed into a tank 6F, pars 0108-0109) and to direct driving of the fluid in a continuous fashion (computer system gives indication to dosing pump 5 to drive fluid whether vaporization circuit is active or dosing valve is open, pars 0110-0111).
23. Regarding claim 14, Goncalves teaches a sterilization system (sterilization device, Title/Abstract) comprising:
a sterilization module (vaporizer/mixer chamber receives chemical sterilizing chemical product from capillary tube drop by drop, pars 0111-0113);
a dosing cylinder (tank 6F, FIG. 1a) coupled to the sterilization module (FIG. 1a, tank 6F and vaporizer/mixer system 4), the dosing cylinder for receiving and measuring a fluid containing one or more chemical components (chemical product is pumped by the filling pump 7 and placed into a tank 6F, par 0109; level of the chemical product is controlled by the level sensor, par 0110), the dosing cylinder including a fluid sensor (level float 6B/level sensor 6A, par 0110, FIG. 1a);
a pump operably coupled to the dosing cylinder (filling pump 7, FIG. 1a), the pump for driving the fluid to the dosing cylinder (chemical product is pumped by the filling pump 7 and placed into a tank 6F, par 0109); and
a controller (computer or control unit, par 0110) in communication with the dosing cylinder and the pump (chemical product tank 6F is provided with a system that controls the float 6B and interacts with the computer or the control unit, par 0110), the controller including a processor and a memory with instructions (process is controlled and programmed by the computer, par 0117) which, when executed, cause the processor to (computer that controls the process, par 0122):
initiate driving of the fluid into the dosing cylinder (chemical product is pumped by the filling pump 7 and placed into a tank 6F, par 0109; an order from the operator starts the refilling sequence, pars 0107-0108),
identify a condition, based on data received from the fluid sensor, the condition indicating that the fluid has reached a predetermined volume in the dosing cylinder (level of the chemical product is controlled by the level or pressure sensor 6A which sends the information to the computer, par 0110), and
initiate driving of the fluid of the predetermined volume from the dosing cylinder (computer system gives indication to the dosing peristaltic pump 5 to start pumping the chemical product from a tank 6F, par 0111) to the sterilization module (introduces the chemical product into the vaporizer/mixer 4G drop by drop through the capillary tube, pars 0111-0113).
Goncalves does not explicitly teach that tank 6F, which is configured to receive and measure doses to perform the functions of the claimed dosing cylinder, is a cylinder. As many fluid containment vessels are known to take the form of a cylinder (including bottle/container 8F of Goncalves, FIGS. 1a-b), making such a tank cylindrical would be a matter of obvious design choice absent persuasive evidence that the particular configuration is significant. See MPEP 2144.04(IV)(B), in re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Goncalves also does not explicitly teach that the controller would stop pumping of the fluid into the dosing cylinder in response to the condition, though it is known that the filling pump 7 fills the tank 6F as a finite action (pars 0107 and 0109) and the level in the tank 6F is controlled by the level sensor 6A (par 0110). In the next sequence of the process, the same controller does send a signal to stop the dosing peristaltic pump 5 after a circulation period (par 0111), teaching a dosing period started by a start command and stopped by a stop command.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the controller of Goncalves to stop pumping of the fluid into the dosing cylinder in response to identifying that the fluid reaches the predetermined level, as Goncalves teaches that the controller can send a stop signal to predictably and reliably control the dosing provided by a pump and that the level sensor controls the level in the dosing cylinder. It would further have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the tank 6F of Goncalves as a cylinder, as such a shape would predictably hold a controllable amount of liquid for distribution into the sterilization system.
24. Regarding claim 15, Goncalves teaches the system of claim 14, wherein the sterilization module comprises an atomizer configured to receive and atomize the fluid (vaporizer/mixer chamber receives chemical sterilizing chemical product from capillary tube drop by drop, pars 0111-0113; ultra-sound system 4I applied to the capillary tubes can also be used to improve the vaporization, par 0118) from the dosing cylinder (chemical product pumped from tank 6F…drop by drop through the capillary tube, par 0111).
25. Regarding claim 16, Goncalves teaches the system of claim 14, further comprising a second pump (dosing peristaltic pump 5, FIG. 1a, pars 0110-0111) configured to drive the fluid from the dosing cylinder to the sterilization module (chemical product is removed from a tank 6F thanks to a dosing pump 5…it introduces the chemical product into one of the vaporizer/mixer’s capillary tubes 4D, par 0110).
26. Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Goncalves (US 20170312378 A1) as applied to claim 4 above, and further in view of Childers et al (US 5,527,507 A).
Regarding claim 5, Goncalves teaches the system of claim 4, further comprising several valves for flow control (FIG. 1a, 4E, 4H, 13A and 13E, pars 0110-0113 and 0116). Although Goncalves teaches a pump between the fluid source and the dosing cylinder (FIG. 1a, peristaltic pump 7), Goncalves does not teach a valve between the fluid source and the dosing cylinder, the valve for regulating flow of the fluid from the fluid source to the dosing cylinder, wherein the valve is operably coupled to the pump.
Childers teaches an analogous accumulator-based liquid metering system for metering a sterilant into a vaporization system for vapor-phase sterilization (Title, Abstract, col 3 lines 8-53) wherein a three-way valve 34 is located between the reservoir 10 and the accumulator 12 (FIG. 2, col 9 lines 50-66). When the three-way valve is opened to allow i.e. regulate flow of the liquid from the fluid source to the accumulator, the metering pump 14 is also started to draw liquid sterilant along that path (col 9 lines 50-66); as such, the valve is operably coupled to the pump and advantageously allows for controllable addition of liquid sterilant into the accumulator i.e. dosing tank (col 9 line 61 - col 10 line 5).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include between the fluid source and dosing cylinder of Goncalves a valve operably coupled to the pump for regulating flow between the fluid source and dosing cylinder as taught by Childers. Doing so would predictably provide the same advantageous flow regulation wherein virtual identical amounts of liquid are measured repeatedly into the dosing cylinder as taught by Childers (col 10 lines 2-5).
27. Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Goncalves (US 20170312378 A1) as applied to claim 1 above, and further in view of Childers II et al (US 20050084411 A1).
28. Regarding claim 9, Goncalves teaches the system of claim 1, wherein the fluid sensor comprises a float sensor configured to detect fluid height (par 0110, 6A-B). Goncalves does not teach an ultrasonic sensor.
Childers II teaches an analogous dosing storage tank for disinfecting solution (Abstract, pars 0017-0027, FIG. 1) wherein the level of the dosing tank is monitored with an ultrasonic level sensor/transmitter (par 0033), enabling the controller to similarly control the flow rates to match predetermined dosing amounts (par 0041) by measuring the volume in the tank (the total volume of feed water directed to the dosing storage tank is measured, pars 0018 and 0033).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to replace the float sensor of Goncalves with an ultrasonic level sensor/transmitter as taught by Childers II. Doing so would predictably provide the same level sensing capability for the dosing cylinder that is readily integrated with a dosing flow control system as demonstrated by Childers II.
29. Regarding claim 10, Goncalves as modified by Childers II teaches the system of claim 9, wherein the controller is further configured to convert the detected fluid height to a fluid volume (the total volume of feed water directed to the dosing storage tank is measured, Childers II par 0018; liquid level in the storage tank is monitored by an ultrasonic level sensor/transmitter, Childers II par 0033).
30. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Goncalves (US 20170312378 A1) as applied to claim 1 above, and further in view of Tremblay et al (US 20130236373 A1).
Regarding claim 11, Goncalves teaches the system of claim 1, further comprising a user interface device coupled to and in communication with the controller (automation system coupled to components that interface with the user that include RFID, TAG, or microchip and system printer, par 0106). However, Goncalves does not teach the user interface device as interpreted under 35 U.S.C. 112(f) to include “a screen or one or more user actuated buttons or triggers to allow to user to read information and alter the sterilization process as desired”.
Tremblay teaches an analogous metering system provided for metering hydrogen peroxide into an evacuated vessel (Abstract, pars ) including a reservoir 220 equipped with a level sensor (par 0040) wherein the control system is provided with a user interface 118, preferably a touch-sensitive liquid crystal display (LCD) screen 118 and a printer 119
allowing the user to receive and transmit information necessary for use of the apparatus (par 0118).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include within the user interface device of Goncalves a touch-sensitive liquid crystal display as taught by Tremblay. Doing so would predictably provide the same capability for the user to receive and transmit information necessary for the use of the system.
Conclusion
31. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Talbert whose telephone number is (703)756-5538. The examiner can normally be reached Mon-Fri 8:00-5:00 Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris 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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/ERIC TALBERT/Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758