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 .
FINAL ACTION
Response to Amendment
The amendment filed on 6/03/2026 has been received and claims 1, 3, 7, 10-11, 14-17, 19-21, 24, 26-27 and 29 are pending.
Claim Objections
Claims 1, 3, 7, 10-11, 14-17, 19-21, 24 and 26 are objected to because of the following informalities:
in line 8 of Claim 1, insert --,-- after “capturing” and after “camera”;
in line 2 of Claim 17, delete “are” after “decontamination events”.
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” and “validator module” in claim 27.
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). The “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).
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” and “image analysis module” 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 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 11 and 14-16 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 11 recites the limitation "the decontamination process" in line 5. There is insufficient antecedent basis for this limitation in the claim.
In Claim 15, it is not clear whether the limitation “one or more comprises” is attempting to set forth that either/or of the listed steps/features.
Claims 14 and 16 are rejected due to their dependence on a rejected claim.
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, 26-27 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Ferrante (WO2020264367) in view of Green (20060051266).
As to Claim 1, Ferrante (‘367) discloses a method, performed by an apparatus including a computer processor (i.e. within 110 - see entire document, particularly p. 3 [0016] – lines 3-6, p. 4 [0018] – lines 5-6, p. 5 [0020] - last 2 lines, p. 17 [0061] – line 5), a camera (105 - 105A; 105B) and a memory (i.e. within 110 - see entire document, particularly p. 3 [0016] – lines 3-6, p. 4 [0018] – lines 5-6, p. 5 [0020] - last 2 lines, p. 17 [0061] – line 4), 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), wherein the computer processor is configured to execute a trained neural network that is pre-trained (315) to identify and classify objects and actions associated with the decontamination procedure (see entire document, particularly Figures 1-5, p. 7 [0028] – p. 13 [0045]), the method comprising:
capturing with the camera (105A; 105B) a video stream of a work area in which the decontamination procedure is carried out by a user (see entire document, particularly Figures 2A-2B, p. 5 [0021], p. 16 [0056]);
analysing the video stream in real time (see entire document, particularly Abstract) using the trained neural network executed by the computer processor (see entire document, particularly p. 17 [0061]) to identify a sequence of 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 the decontaminating composition of the decontamination system to the medical device using the wipe (i.e. steps 410 and/or 415 - see entire document, particularly Figures 2A-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, pp. 15-16 [0051]-[0053]);
determining, with the computer processor (see entire document, particularly p. 17 [0061]), based on the identified sequence of two or more decontamination events, if the decontamination procedure has been completed (i.e. step 415 - see entire document, particularly Figures 3-5, pp. 15-16 [0053], p. 16 [0055]); and
upon determining that the decontamination procedure has been completed, causing a corresponding indication (515) to be provided to the user (i.e. step 420 - see entire document, particularly Figures 3-5, p. 16 [0055]).
While Ferrante (‘367) discloses that 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]), Ferrante (‘367) does not appear to specifically teach that a decontaminating composition of the decontamination system is applied to the wipe as a foam wherein one of the two or more decontamination events comprises application of the foam to the wipe.
It was known in the art before the effective filing date of the claimed invention to provide a decontaminating composition of a decontamination system as a foam applied to a wipe and to a system in a method of decontamination. Green (‘266) discloses a decontamination system and a (see Figure 5) comprised of a wipe (18/20; 30; 40) (see Figures 2 and 5-8) and a decontaminating composition dispenser (2) (see Figures 1, 3 and 5) where the decontaminating composition dispenser (2) applies a decontaminating composition (12) as a foam (see entire document, particularly p. 3 [0050] – p. 4 4 [0052]) and a method of decontamination comprising a step of applying the decontaminating composition (12) of the decontamination system in the form of a foam to the wipe (see entire document, particularly p. 4 [0056]) and a step of wiping a surface of medical device with the wipe with the foam in order to mix reagents of the decontamination composition and to sterilize the medical device (see entire document, particularly p. 4 [0056]-[0057]). It would have been obvious to one of ordinary skill in this art before the effective filing date of the claimed invention to provide a decontamination system of Green where the decontaminating composition is applied to the wipe as a foam as the decontamination system of Ferrante in order to mix and activate the decontaminating composition as well as to enable sterilization of the medical device as shown by Green.
Furthermore, as Ferrante (‘367) discloses that the step “to identify a type of cleaning agent based on a brand name or label appearing in the video stream [and/or] by an application method of the cleaning agent” and to, ”[b]ased on [this identified] information,” access and “select [an appropriate] cleaning protocol to be applied to the cleaning[/decontamination] attempt” (see entire document, particularly p. 13 [0045] – lines 1-2, 6-9 and 12-13), it would have been obvious to and well within the purview of one of ordinary skill in the art before the effective filing date of the claimed invention for the neural network of Ferrante to also be trained to identify in the video stream a decontamination event of applying the foam to the wipe as “an application method of the cleaning agent” in order to allow selection of a correct cleaning/decontamination protocol to be applied by a user in the decontamination procedure. Only the expected results would be attained.
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, and comparing the cumulative time to a predetermined minimum contact time (see entire document, particularly Figure 5, p. 16 [0056]-[0057]).
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, 340), implemented by a processor (i.e. within 110 – see entire document, particularly p. 3 [0016] – lines 3-6, p. 4 [0018] – lines 5-6, p. 5 [0020] - last 2 lines, p. 17 [0061] – lines 3-6) and comprising a neural network-based classifier (315, 320, 325) that is pre-trained to identify and classify objects and actions associated with the decontamination procedure (see entire document, particularly Figures 1 and 3-5, pp. 7-8 [0028] - p. 10 [0035]), the image analysis module (150 - 305, 315, 320, 325, 330, 335, 340) configured to receive the video stream and to identify a sequence of 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
a validator module (110, 150, 330, 335, 345 - see entire document, particularly Figures 1 and 3-5, p. 3 [0016] – lines 4-6), implemented by the processor (i.e. within 110 – see entire document, particularly p. 3 [0016] – lines 3-6, p. 4 [0018] – lines 5-6, p. 5 [0020] - last 2 lines, p. 17 [0061] – lines 3-6) and configured to determine, based on the identified two or more decontamination events (see entire document, particularly p. 8 [0029]), if the decontamination procedure has been completed (via 315, 320, 325,330, 335 - see Figures 3-5), and to cause the output device (110, 515) (via 345 - see Figures 1, 3 and 5) to provide a corresponding indication to the user upon determining that the determination procedure has been completed (see Figures 1 and 3-5).
While Ferrante (‘367) discloses that 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]), Ferrante (‘367) does not appear to specifically teach that the decontaminating composition of the decontamination system is applied to the wipe as a foam such that the image analysis module is configured to identify in the video stream where one of the two or more decontamination events comprises application of the foam to the wipe.
It was known in the art before the effective filing date of the claimed invention to provide a decontaminating composition as a foam and apply the foam to a wipe in a decontamination system. Green (‘266) discloses a decontamination system (see Figure 5) comprised of a wipe (18/20; 30; 40) (see Figures 2 and 5-8) and a decontaminating composition dispenser (2) (see Figures 1, 3 and 5) where the decontaminating composition dispenser (2) applies a decontaminating composition (12) as a foam (see entire document, particularly p. 3 [0050] – p. 4 4 [0052]) and a method of decontamination comprising a step of applying the decontaminating composition (12) of the decontamination system in the form of a foam to the wipe (see entire document, particularly p. 4 [0056]) and a step of wiping a surface of medical device with the wipe with the foam in order to mix reagents of the decontamination composition and to sterilize the medical device (see entire document, particularly p. 4 [0056]-[0057]). It would have been obvious to one of ordinary skill in this art before the effective filing date of the claimed invention to provide a decontamination system of Green where the decontaminating composition is applied to the wipe as a foam as the decontamination system of Ferrante in order to mix and activate the decontaminating composition as well as to enable sterilization of the medical device as shown by Green.
Furthermore, as Ferrante (‘367) discloses that the image analysis module is configured “to identify a type of cleaning agent based on a brand name or label appearing in the video stream [and/or] by an application method of the cleaning agent” and to, ”[b]ased on [this identified] information,” access and “select [an appropriate] cleaning protocol to be applied to the cleaning[/decontamination] attempt” (see entire document, particularly p. 13 [0045] – lines 1-2, 6-9 and 12-13), it would have been obvious to and well within the purview of one of ordinary skill in the art before the effective filing date of the claimed invention for the image analysis module of Ferrante to also be trained to identify in the video stream a decontamination event of applying the foam to the wipe as “an application method of the cleaning agent” in order to allow selection of a correct cleaning/decontamination protocol to be applied by a user in the decontamination procedure. Only the expected results would be attained.
As to Claims 26 and 29, Ferrante (‘367) discloses that the validator module (110, 150, 330, 335, 345) is further 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).
Thus, Claims 1, 3, 26-27 and 29 would have been obvious within the meaning of 35 U.S.C. 103 over the combined teachings of Ferrante (‘367) and Green (‘266).
Allowable Subject Matter
Claims 7, 10, 17, 19-21, and 24 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the combined teaching of prior art of Ferrante (WO2020264367) and Green (20060051266) does not specifically teach each of the features as set forth in the dependent claims listed above.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 27 have been considered but are moot because the new ground of rejection does not rely on the same combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 6/03/2026 have been fully considered but they are not persuasive.
Specifically, as to applicant’s argument in last 11 lines on p. 12 to line 2 on p. 13 of Remarks, examiner disagrees and points out that the neural network-based classifier of Ferrante does meet the newly added limitation as discussed in the paragraph 9 set forth above for the rejection of claim 27.
As to applicant’s argument in last line on p. 13 to line 3 on p. 15 and in lines of Remarks, examiner disagrees and points out that Ferrante (in lines 6-9 and 12-13 of [0045] on p. 13) does teach that “the neural network-based classifier [is used] to identify, as part of the real-time validation process, as part of the real-time validation process, any event that occurs prior to application of the cleaning agent to the surface” where the teaching in lines 12-13 to utilize the identification via a brand name or label appearing in a video stream to determine and select an appropriate cleaning protocol to be applied (i.e. from 310 – see Figure 3) for a cleaning procedure/protocol clearly shows utilization/evaluation of at least one pre-cleaning event via a neural network-based classifier (i.e. via 315 – see Figure 3).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REGINA M YOO whose telephone number is (571)272-6690. The examiner can normally be reached Monday - Friday, 9:00 am - 5:00 pm EST.
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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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/REGINA M YOO/ Primary Examiner, Art Unit 1758
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