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 .
DETAILED ACTION
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 10/15/2025 is acknowledged. The traversal is on the ground(s) that due to amendment of the claims the groups I-II share an additional same or corresponding special technical feature of “identification and analysis of multiple decontamination events, including the application of a foam to a wipe, to verify proper completion of a decontamination procedure” which is not taught by Ferrante. This is found persuasive.
The restriction is withdrawn and all claims are examined.
Claim Objections
Claims 1-3, 5, 7, 10-11, 14-17, 19-21, 24, and 26-29 are objected to because of the following informalities:
in line 9 of Claim 1, insert --two or more-- before “decontamination events”;
in line 11 of Claim 1, delete “or”;
in line 16 of Claim 1,
insert --another-- before “one”,
insert --two or more-- before “decontamination events”;
in line 1 of Claims 2-3, 5, 7, 10-11, 14-17, 19-21, 24, and 26, delete “A” and insert --The--;
in line 1 of Claim 2, insert --the-- before “analysing”;
in line 2 of Claim 2,
insert --two or more-- before “decontamination”,
delete “event” and insert --events--;
in line 3 of Claim 2, insert --two or more-- before “decontamination events”;
in line 2 of Claim 3, insert --the-- before “determining”;
in line 3 of Claim 7, insert --the-- before “determining”;
in line 2 of Claim 10, insert --the-- before “determining”;
in line 4 of Claim 11, insert --and-- after “process;”;
in line 5 of Claim 11,
delete “and”,
delete “an alert event” and insert --one of the one or more alert events--;
in line 1 of Claim 14, delete “alert”;
in line 2 of Claim 14,
delete “event or”,
insert --one or more-- before “alert events”;
in line 3 of Claim 14, insert --medical-- before “device”;
in line 1 of Claim 15, delete “alert”;
in line 2 of Claim 15,
delete “event or”,
insert --one or more-- before “alert events”,
insert --at least one of-- before “the user’s”;
in line 3 of Claim 15, delete “/or”;
in line 1 of Claim 16, delete “alert”;
in line 2 of Claim 16,
delete “event or”,
insert --one or more-- before “alert events”,
insert --medical-- before “device”;
in line 4 of Claim 16, insert --medical-- before “device”;
in line 1 of Claim 17, delete “in which” and insert --, wherein the identified-- after “Claim 1”;
in line 2 of Claim 17, delete “are identified, one of the decontamination events” and insert --further--;
in line 3 of Claim 17, delete “said applying the decontaminating composition to the device and”;
in line 4 of Claim 17,
delete “one of the decontamination events comprising” and insert --decontamination event of--,
insert --decontaminated medical-- before “device”;
in line 1 of Claim 19, delete “in which” and insert --wherein the identified-- before “two”;
in line 2 of Claim 19, delete “are identified, one of the decontamination events” and insert --further--;
in line 3 of Claim 19, delete “said applying the decontaminating composition to the device and”;
in line 4 of Claim 19, delete “one of the decontamination events comprises the presentation of” and insert --decontamination event of presenting--;
in line 1 of Claim 20, insert --further-- before “comprising”;
in line 1 of Claim 21, insert --further-- before “comprising”;
in line 2 of Claim 21,
insert --at least one of-- after “obtain”,
delete “/or”;
in line 1 of Claim 24, insert --at least one of-- before “the”;
in line 2 of Claim 24, delete “/or”;
in line 1 of Claim 26, insert --further-- before “comprising”;
in line 1 of Claim 27, delete “Apparatus” and insert --An apparatus--;
in line 7 of Claim 27, insert spacing before “an image”;
in line 10 of Claim 27, insert --two or more-- before “decontamination events”;
in line 12 of Claim 27, delete “or” before “each”;
in line 17 of Claim 27,
insert --another-- before “one”, and
insert --two or more-- before “decontamination events”;
in line 1 of Claims 28-29, delete “An” and insert --The--.
Appropriate correction is required.
Claim Interpretation
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.
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.
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: “output device’, “image analysis module” and “validator module” in claim 27; “logging module” in claim 29.
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. Specifically, “output device” is being interpreted to cover the corresponding structure such as a display and/or smartphones, tablet computers and similar devices (see [0049] and [0060] of published application); “image analysis module” is being interpreted to cover the corresponding structure such as software for execution by the processor such as installable application that runs within a device operation system environment or a trained artificial neural network such as a convolutional neural network and/or a recurrent neural network such as based on MobileNet combined with an LTSM recurrent neural network (see [0049] and [0052]-[0053] of published application); “validator module” is being interpreted to cover the corresponding structure such as software for execution by the processor such as installable application that runs within a device operation system environment, employing a finite state machine or a hidden Markov model (see [0049] and [0059] of published application). The limitation of “logging module” is being interpreted to cover the corresponding structure same as the validator module, namely software for execution by the processor such as installable application that runs within a device operation system environment, employing a finite state machine or a hidden Markov model as discussed above and/or smartphones, tablet computers and similar devices (see [0046], [0049], [0060] and [0090] of published application).
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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “camera system” in claim 27.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 29 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, there is no written description support for a separate corresponding structure or material for performing the entire claimed function of a “logging module” (other than that of the validator module and/or output device) within the Specification.
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.
Claims 1-3, 5, 7, 10-11, 14-17, 19-21, 24, and 26-29 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 1 recites the limitation "the decontamination composition" in line 15. There is insufficient antecedent basis for this limitation in the claim. It is suggested to correct the language to “the decontaminating composition”.
Claim 5 recites the limitation "the decontamination composition" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. It is suggested to correct the language to “the decontaminating composition”.
In Claim 5, it is not clear whether the claim is attempting to set forth that the foam that is applied to the wipe is “absorbed or impregnated in the wipe” prior to the application to the medical device or that the claim is attempting to set forth an alternate form/configuration of the decontaminating composition and/or decontaminating composition application procedure.
Claim 27 recites the limitation "the decontamination composition" in line 16. There is insufficient antecedent basis for this limitation in the claim. It is suggested to correct the language to “the decontaminating composition”.
Claim 28 recites the limitation "said one or more decontamination events" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. It is suggested to correct the language to “said two or more decontamination events”.
In Claim 29, claim limitation “logging module” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. One structure described in the specification which performs the function of “logging” is the structure of the “validator module” and/or “output device” rather than for a separate and distinct component corresponding to a “logging module”. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 2-3, 7, 10-11, 14-17, 19-21, 24, and 26 are rejected based on their dependence on a rejected claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claim recites “determining, based on the each identified decontamination event, if the decontamination procedure has been completed” as well as “analysing the video stream to identify two or more decontamination events in the video stream…”, as drafted, are a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitations in the mind, then it falls within the “Mental Processes” grouping of abstract ideas (see MPEP 2106.04(a)).
This judicial exception is not integrated into a practical application because the step of “upon determining that the decontamination procedure has been completed, causing a corresponding indication to be provided to the user” does not recite a particular indicator or means that provide an indication to a user and is stated at a high level without reciting how a structure such as an indicator or a computer may effect this application. The step of “capturing a video stream of a work area…” also does not recite a particular capturing means such as a camera to capture a video stream and is stated at a high level without reciting how a computer/camera may effect this application. This is instead merely instructions to “apply” the exception in a generic way and/or is merely extra-solution activity (e.x.: such as obtaining data, outputting data, sending a signal) which does not impose meaningful limits and does not integrate the judicial exception into a practical application (see MPEP 2106.05(d)/(g)).
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the step of “causing a corresponding indication to be provided to the user” in addition to the step of “capturing…” are well-understood, routine, conventional activities (see, for example, Ferrante (WO2020264367)) and thus, the claim does not recite significantly more than a judicial exception. In addition, “upon determining that the … has been completed, causing a corresponding indication to be provided to the user” is an insignificant extra-solution activity. Moreover, indicating that the claimed method is “for validating a decontamination procedure performed on a medical device using a …a wipe” amounts to merely indicating a field of use or technological environment in which to apply the judicial exception, and does not amount to significantly more than the exception itself. Thus, there is not an inventive concept and the claim is not patent eligible.
Claim 2 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more, similarly as in the parent claim 1 as set forth above. The claim(s) recite(s) “analysing the video…to identify…” which falls within the “Mental Processes” grouping of abstract ideas (see MPEP 2106.04(a)). This judicial exception is not integrated into a practical application because the broad use of a “trained neural network” to perform an analysis is merely recited as a tool to perform an existing process and serve merely as a tool to execute the abstract idea and thus, it is not a practical application (see MPEP 2106.05(f)). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the step of “identifying…” does not amount to significantly more than the exception itself as such step is also a well-understood, routine, conventional activity. Thus, there is not an inventive concept and the claim is not patent eligible.
Claims 3, 7, 10, 21 and 26 are rejected under 35 U.S.C. 101 for the same reason(s) as claim 1 above because the additional steps of claim(s) also recite(s) “determining…”, “comparing…”, and “analysing…”and are also directed to abstract ideas without significantly more. The judicial exception is not integrated into a practical application as discussed above for parent claim 1 and the claims do not include any additional elements which would be sufficient to amount to significantly more than the judicial exception. Thus, there is not an inventive concept and the claim is not patent eligible.
Claims 11 and 20 are rejected under 35 U.S.C. 101 for the same reason as claim 1 above since steps of “identifying…”, “causing a corresponding alert…”, “obtaining information…”, “checking if….are compatible by cross-referencing…”, “causing a corresponding indication of compatibility or non-compatibility to be provided to the user”, and “electronically logging…” do not recite a particular means to accomplish the steps and are stated at a high level without reciting how a computer/particular means may effect this application. This is not particular and is instead merely instructions to “apply” the exception in a generic way and/or is merely extra-solution activity. Moreover, claims do not include any additional elements that are sufficient to amount to significantly more than the judicial exception because the step of “identifying…”, “causing a corresponding alert…”, “obtaining information…”, “checking if….are compatible…”, “causing a corresponding indication of compatibility or non-compatibility to be provided to the user”, and “electronically logging…” are well-understood, routine, conventional activities (see, for example, Ferrante (WO2020264367)) and thus, the claim does not recite significantly more than a judicial exception. Thus, there is not an inventive concept and the claim is not patent eligible.
Claims 5, 17 and 19 are rejected under 35 U.S.C. 101 for the same reason as claim 1 above since the limitation of claim 5 does not further limit any of the process steps but rather merely limiting the content of the video stream (i.e. decontamination events) and do not amount to significantly more than the exception/abstract idea/mental process itself as set forth in the parent claim 1.
Claims 14-16 are rejected under 35 U.S.C. 101 for the same reason as claim 1/claim 11 above since the limitation of claims 14-16 do not further limit any of the process steps but rather merely the content of the video stream (i.e. alert event) and do not amount to significantly more than the exception/abstract idea/mental process itself as set forth in the parent claims 1 and 11.
Claim 24 is rejected under 35 U.S.C. 101 for the same reason as claim 1/claim 20 above since the limitation of claim 24 does not further limit the determination step but rather merely the content of the information used for the determination step and does not amount to significantly more than the exception/abstract idea/mental process itself as set forth in the parent claims 1 and 20.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 27-29 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ferrante (WO2020264367).
As to Claim 27, Ferrante (‘367) discloses an apparatus for validating a decontamination procedure performed on a medical device using a decontamination system comprising a wipe (see entire document, particularly Figures 1-5, Abstract), the apparatus comprising:
a camera system (105) (see Figure 1) for capturing a video stream of a work area in which the decontamination procedure is carried out by a user (see Figures 2A-2B and 5);
an output device (110, 515) (via 345 - see Figures 1, 3 and 5) for providing audio, textual and/or visual indications to a user;
an image analysis module (150, 305, 315, 320, 325) configured to receive the video stream and to identify two or more decontamination events in the video stream that correspond with the decontamination procedure being correctly performed, one of the two or more decontamination events comprising applying a decontaminating composition of the decontamination system to the medical device using the wipe/towelette via wiping (see entire document, particularly Figures 2A, 3 and 5, p. 4 [0019], p. 8 [0029] – lines 7-8 and [0030] – lines 7-8, p. 9 [0032]-[0033], pp. 9-10 [0034] – 2nd line from the bottom) and another one of the two or more decontamination events comprises application of the decontaminating composition via spraying or rinsing with one or more liquids directly to a surface of the medical device (see entire document, particularly Figures 2A-5, p. 4 [0019], p. 8 [0029] – lines 9-11 and [0030] – lines 7-8, p. 9 [0033]-[0034]); and
a validator module (110, 150, 330, 335, 340, 345) (see entire document, particularly Figures 1 and 3-5, p. 3 [0016] – lines 4-6) configured to determine, based on the each identified decontamination event (see entire document, particularly p. 8 [0029]), if the decontamination procedure has been completed (via 315, 320, 325 - see Figures 3-4), and to cause the output device to provide a corresponding indication to the user upon determining that the determination procedure has been completed (see Figures 1 and 3-5).
As to the limitation that the image analysis module is configured to identify a decontamination event comprising application of the decontaminating composition in the form of a foam to the wipe, since Ferrante (‘367) discloses the same corresponding structure (see, for example, p. 8 [0030] – lines 7-8) for the image analysis module (which is being interpreted under 35 U.S.C. 112(f) and interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof, as discussed in the paragraphs 5-6 above), Ferrante (‘367) is deemed to meet the claimed limitation of also being configured to identify a decontamination event comprising application of the decontaminating composition in the form of a foam to the wipe.
As to Claim 28, Ferrante (‘367) discloses that the image analysis module comprises a neural network-based classifier (320, 325) trained to recognize said two or more decontamination events in the video stream (see entire document, particularly Figures 1 and 3-5, p. 8 [0029] to p. 10 [0035]).
As to Claim 29, Ferrante (‘367) discloses that the apparatus further comprises a logging module (110) (see Figures 1 and 5) configured to electronically log that the decontamination procedure has been completed (see entire document, particularly Figures 1 and 5, p. 17 [0058] – last 3 lines).
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-3, 5, 10-11 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Ferrante (WO2020264367).
As to Claims 1 and 5, Ferrante (‘367) discloses a method for validating a decontamination procedure performed on a medical device using a decontamination system comprising a wipe (see entire document, particularly Figures 1-5, Abstract), the method comprising:
capturing a video stream of a work area in which the decontamination procedure is carried out by a user (via 105 - see Figures 1-2B and 5);
analysing the video stream (via 150, 305, 315, 320, 325) to identify two or more decontamination events in the video stream that correspond with the decontamination procedure being correctly performed on the medical device, one of the two or more decontamination events comprising applying a decontaminating composition of the decontamination system to the medical device using a wipe/towelette via wiping (see entire document, particularly Figures 2A and 5, p. 4 [0019], p. 8 [0029] – lines 7-8 and [0030] – lines 7-8, p. 9 [0032]-[0034]) and another one of the two or more decontamination events comprises application of the decontaminating composition via spraying or rinsing with one or more liquids directly to a surface of the medical device (see entire document, particularly Figures 2A-5, p. 4 [0019], p. 8 [0029] – lines 9-11 and [0030] – lines 7-8, p. 9 [0033]-[0034]);
determining, based on the each identified decontamination event, if the decontamination procedure has been completed (via 315, 320, 325 - see Figures 3-4) (see entire document, particularly p. 8 [0029]); and
upon determining that the decontamination procedure has been completed, causing a corresponding indication to be provided to the user (via 110, 515) (via 345 - see Figures 1, 3 and 5).
While Ferrante (‘367) does not appear to specifically teach that the step of analysing the video stream to identify two or more decontamination events comprises identifying application of a foam to the wipe during the decontamination procedure, Ferrante (‘367) discloses that alternative methods of applying the decontaminating composition to a surface are identified during the analysis step in order to detect any decontamination activity (see entire document, particularly p. 9 [0033] – lines 5-6, p. 13 [0045]) and application of an alternate decontaminating composition to a surface are identified in order to detect a decontamination activity of (see entire document, particularly p. 13 [0045]). Moreover, as it was well known in the art before the effective filing date of the claimed invention to apply a decontaminating composition to a medical device in multitude of manners such as direct or indirect application of the decontaminating composition to a medical device (such as wetting via dipping/soaking in the decontaminating composition, via applying/wiping with a substrate such as a wipe pre-applied/absorbed/impregnated with the decontaminating composition, dispersing directly applied decontaminating composition with an applicator/substrate) and that a decontaminating composition may be available in a variety of forms such as a liquid, gel, and foam among others, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to identify as one of the two or more decontamination event an application of the decontaminating composition in the form of foam to the wipe and to absorb/impregnate the decontaminating composition in the wipe in the method of Ferrante as a known alternate form of the decontaminating composition and as a known alternate process of applying a decontaminating agent to a medical device in order to ensure identification of all decontamination efforts by a user so as correctly validate that the decontamination procedure has been performed despite use of an alternate method of decontaminating composition application. Only the expected results would be attained.
As to Claim 2, Ferrante (‘367) discloses that the analysing the video stream comprises using a trained neural network to identify the two or more decontamination events or at least one of the two or more decontamination events (see entire document, particularly Figures 1 and 3-5, p. 8 [0028] to p. 10 [0035] specifically p. 8 [0030] – lines 7-8).
As to Claim 3, Ferrante (‘367) discloses that the determining if the decontamination procedure has been completed comprises determining a cumulative time for which the decontaminating composition is in contact with the medical device (see Figure ), and comparing the cumulative time to a predetermined minimum contact time (see Figure 5).
As to Claim 10, Ferrante (‘367) discloses that the determining if the decontamination procedure has been completed comprises determining if the wipe has been applied to all of a target area of the medical device (see entire document, particularly p. 9 [0033] – lines 1-3, p. 10 [0035] – 3rd – 5th lines from the bottom).
As to Claim 11, Ferrante (‘367) discloses that the method further comprising:
when analysing the video stream, identifying one or more alert events in the video stream that corresponds with potential errors being made during performance of the decontamination process (see entire document, particularly Figure 5, p. 17 [0058] – lines 1-3); and
upon identification of one of the one or more alert events, causing a corresponding alert (525) to be provided to the user (see entire document, particularly Figure 5, p. 17 [0058] – lines 3-5).
As to Claim 26, Ferrante (‘367) discloses that the method further comprising electronically logging that the decontamination procedure has been completed (i.e. at 515 - see Figure 5).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following references relate either to the field of the invention or subject matter of the invention, but are not relied upon in the rejection of record: 12249144 (US equivalent to Ferrante (WO2020264367) – see discussion/rejection above), 20190122047 (a method and an apparatus for monitoring and validating a tool reprocessing).
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/REGINA M YOO/ Primary Examiner, Art Unit 1758