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
Response to Amendment
The amendment filed on 4/29/2026 has been received and claims 1-17 are pending.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/29/2026 has been entered.
Election/Restrictions
Claims 9-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/10/2025.
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: “evaluation unit” in claim 1; “visualization unit” in claims 3 and 7.
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, the corresponding structure for the “evaluation unit” comprises at least one computing module and/or a processor (see Specification, p. 5 [0014]). The corresponding structure for the “visualization unit” comprises a display, a monitor, a projection unit such as one projecting a colored light (see Specification, pp. 7-8 [0021]).
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: “surface sensor unit” in claims 1 and 2.
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.
Claim 8 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 8 recites the limitation "the…medical imaging examination information" in line 2. There is insufficient antecedent basis for this limitation in the 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) 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Reid (20120116803) in view of Marsden (20130187775) and Shelton IV (20190206564).
As to Claim 1, Reid (‘803) discloses a method for providing cleaning information for at least one surface of a medical device (see entire document, particularly Figures 1-5), comprising:
recording (via 22, 41, and/or 2, 24, 43) contact data indicating contact between a person and at least one surface of the medical device (i.e. permanently installed in room or mobile unit such as 3) (see entire document, particularly p. 2 [0024]), wherein the contact data is recorded (via 24, 43) by at least one surface sensor unit (10, 12) that is configured to record physical touch of the at least one surface by a person (see entire document, particularly Figure 1, p. 1 [0021], p. 2 [0024]-[0025]);
evaluating (via 22, 24, 26) the contact data by an evaluation unit (22, 24, 26, 32), wherein the evaluation of the contact data comprises identifying those surfaces of the medical device which indicate a contact with or a physical proximity to a person (see entire document, particularly Figure 1, p. 2 [0022]-[0023], p. 3 [0031] – lines 8-9 and [0032]); and
generating cleaning information for the identified surfaces on the basis of the evaluated contact data and providing the cleaning information for the identified surfaces (i.e. steps 94, 96, 110; 120, 122, 124, 126, 136, 138 - see Figures 4-5).
Reid (‘803) does not appear to specifically teach that the at least one surface sensor unit is configured to record physical touch of the at least one surface by a person during use of the medical imaging device where the contact data indicates which surfaces were physically touched by the person, or that the medical device in a room of a medical establishment/building, including a hospital, is a medical imaging device.
As to the limitation that contact data is recorded by the at least one sensor unit during use of the medical imaging device as to which surfaces were physically touched by a person, it was known in the art before the effective filing date of the claimed invention to provide at least one surface sensor unit configured to record physical touch of the at least one surface by a person during use of a medical imaging device where the contact data indicates which surfaces were physically touched by the person. Marsden (‘775) disclose a method for providing cleaning information for at least one surface (300) capable of being of an object such as a medical imaging device (see entire document, particularly Figures 1-4C, p. 1 [0012]-[0013], p. 4 [0064]), comprising:
recording (via 310, 360, 372, 380) contact data indicating contact between a person and at least one surface (300) capable of being an object such as a medical imaging device (see entire document, particularly Figures 3-4B, p. 4 [0059] – particularly line 11), wherein the contact data is recorded by at least one surface sensor unit (120; 320, 330) configured to record physical touch of the at least one surface (300) by a person during use of the medical imaging device (i.e. steps 4110, 4115, 4200, 4210, 4220, 4230, 4240 - see entire document, particularly Figures 3-4B, p. 4 [0056], p. 5 [0065]), the contact data indicating which surfaces (100, 300) were physically touched by the person (see entire document, particularly Figures 1 and 3, p. 1 [0002] and [0012]-[0013], p. 2 [0017] and 0023], p. 5 [0065]);
evaluating the contact data by an evaluation unit (310) (i.e. steps 4115 - see entire document, particularly Figure 4A), wherein the evaluation of the contact data comprises identifying those surfaces (300) of the object capable of being a medical imaging device which indicate a contact with (via 320) or a physical proximity to (via 330) a person (i.e. step 4210 - see entire document, particularly Figures 3-4B, p. 4 [0059]); and
recording (via 310, 360, 373, 380) contact data indicating contact between a person and at least one surface (300) capable of being an object such as a medical imaging device (see entire document, particularly Figures 3-4B, p. 4 [0060]-[0062]), wherein the contact data is recorded by at least one surface sensor unit (320, 330) configured to record physical touch of the at least one surface (300) by a person during cleaning of the medical imaging device (i.e. steps 4130, 4140, 4300, 4310, 4320, 4325, 4330 - see entire document, particularly Figures 3-4A and 4C, p. 4 [0060] to p. 5 [0065]), the contact data indicating which surfaces (100, 300) were physically touched by the person (see entire document, particularly Figures 1 and 3, p. 1 [0002] and [0012]-[0013], p. 2 [0017] and 0023], p. 5 [0065])
in order to monitor and determine a need for a cleaning based on a detected contamination level/threshold so as to prevent infection proactively to reduce costs in time, money and human suffering (see entire document, particularly Figures 4A-4B, p. 1 [0011], p. 3 [0050]).
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 step of recording contact data of physically touching of one or more surfaces by a person during use of the medical device in the method of Reid as a known process step in order to monitor and determine a need for a cleaning process for an object/medical device to prevent infection so as to lower costs in time, money and human suffering as shown by Marsden.
As to the limitation that the medical device is a medical imaging device, it was known in the art before the effective filing date of the claimed invention to provide a medical imaging device in a room of a hospital as a medical device. Shelton IV (‘564) discloses a method for providing cleaning at least one surface of a medical device in the form of a medical imaging device (124) in a room of a medical establishment/building such as a hospital in order to sterilize all items that comes in contact with a patient or that penetrates a sterile field (see entire document, particularly p. 10 [0226]). It would have been obvious to one of ordinary skill in this art before the effective filing date of the claimed invention that a medical device present in a room of a medical building such as a hospital in the method of Reid as modified by Marsden includes a medical imaging device as a known item in a room of a medical setting as shown by Shelton IV.
As to Claim 2, while Reid (‘803) does not appear to specifically teach that the medical device has two or more housing parts, each having a surface sensor unit, as Shelton IV (‘564) that a medical imaging device (124) as well as all its attachments and components need to be sterilized (see entire document, particularly p. 10 [0226] – lines 7-9), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a surface sensor unit with all/each of the components of the medical imaging device in the method of Reid as modified by Marsden and Shelton IV in order to detect and determine the cleanliness status of the medical imaging device as well as to track and ensure that all components of the medical imaging device is sterilized/cleaned. Only the expected results would be attained.
As to Claim 3, Reid (‘803) discloses that the cleaning information for the identified surfaces is presented to a user visually by a visualization unit (18, 28, 34, 38) (see entire document, particularly p. 3 [0030]-[0031], p. 4 [0039]-[0040]).
As to Claim 4, Reid (‘803) discloses that the cleaning information comprises a cleaning plan (54 and/or cleaning protocol) for cleaning the identified surfaces (see entire document, particularly p. 3 [0031] – lines 1-3, pp. 4-5 [0040] – lines 8-10 and 14-21).
As to Claim 5, Reid (‘803) discloses that a cleaning operation in accordance with the cleaning plan is performed in a subsequent method step after generating the cleaning information (see entire document, particularly p. 3 [0031] – lines 1-4 where the check list of chores/cleaning operation/plan (i.e. room cleaning protocol) is generated prior to performance of the room cleaning and the check list is checked off while performing the room cleaning).
As to Claim 6, Reid (‘803) discloses that a cleaning of the identified surfaces is recorded (see entire document, particularly p. 2 [0023]-[0024], p. 3 [0028], p. 4 [0036]).
As to Claim 7, Reid (‘803) discloses that a cleaning progress of a cleaning of the identified surfaces is presented visually (ex: via 44, 52) to a user by a visualization unit (28, 34, 38) (see entire document, particularly p. 4 [0036] – lines 6-8 and [0039] – 4th – 5th lines from the bottom, pp. 4-5[0040] – lines 6-7, 14-15, and last 6 lines).
As to Claim 8, Reid (‘803) discloses that the cleaning information is stored together with the cleaning progress or medical imaging examination information (see entire document, particularly Figures 4-5, p. 2 [0023]-[0026], p. 4 [0035]-[0036] and [0038]).
Thus, Claims 1-8 would have been obvious within the meaning of 35 U.S.C. 103 over the combined teachings of Reid (‘803), Marsden (‘775) and Shelton IV (‘564).
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Reid (20120116803) in view of Marsden (20130187775) and Shelton IV (20190206564) as applied to claim 1 above, and further in view of Callahan (20210346561).
Reid (‘803), Marsden (‘775) and Shelton IV (‘564) are relied upon for disclosure described in the rejection of claim 1 under 35 U.S.C. 103.
Neither Reid (‘803) nor Marsden (‘775) or Shelton IV (‘564) appears to specifically teach that the cleaning information for the identified surfaces is provided by controlling a projection unit to illuminate the identified surfaces with a visually distinguishable color.
It was known in the art before the effective filing date of the claimed invention to provide a projection unit to illuminate the identified surfaces with a visually distinguishable color in a method disinfecting surfaces. Callahan (‘561) discloses a method of cleaning/disinfecting surfaces comprising a step of generating/providing cleaning information for identified surfaces by controlling (via 150) a projection unit (130) to illuminate the identified surfaces with a visually distinguishable color (131) in order to provide a visual cue to disinfect surfaces of an area to be disinfected so as to ensure a correct sterilant dose/sterilization duration has been delivered/applied (see entire document, particularly Figures 1-3A and 35, p. 4 [0083]-[0085] and [0087]-[0089]). 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 projection unit to illuminate the identified surfaces with a visually distinguishable color in the method of Reid as modified by Marsden and Shelton IV as a known step in order to guide the sterilization so as to ensure a correct sterilization dose/duration has been applied to the surfaces as shown by Callahan.
Thus, Claim 17 would have been obvious within the meaning of 35 U.S.C. 103 over the combined teachings of Reid (‘803), Marsden (‘775), Shelton IV (‘564), and Callahan (‘561).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 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.
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: 20190117812 (a method of tracking touch using one or more sensors).
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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/REGINA M YOO/ Primary Examiner, Art Unit 1758