DETAILED ACTION
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 .
Response to Arguments
Claim Rejections-35 U.S.C. § 112(b)
The rejections under 35 U.S.C. § 112(b) have been withdrawn.
Claim Interpretation-35 U.S.C. § 112(f)
Applicant argues the terms "optical detection device," "processing unit," and "storage module" are terms recognized in the art. Applicant does not provide any support that these terms are names of structure for performing their respective claimed functions. As to the "optical detection device comprises a camera," the term optical detection device is no longer interpreted under 35 U.S.C. § 112(f) because sufficient structure is recited.
Claim Rejections-35 U.S.C. § 103
Applicant’s arguments with respect to claim(s) 1-14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
As to the checking of a kit of surgical instrument, please note that Montano, Sayani, and Simson show image analysis for checking completeness of kits.
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:
recognition engine in claims 1-14,
processing unit in claims 1-14.
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 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.
Claim(s) 1, 2, and 4-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tamarozzi (US 2022/0313388) in view of Sayani et al. (US 2018/0204323).
Tamarozzi shows a method for recomposition of a kit of surgical instruments as follows:
1. A method for checking a kit of surgical instruments contained inside a container, the method comprising the steps of:
- making available a recognition engine trained by means of reference images of single instruments (Para. [0041]:"a data processing system comprising a programmable central processing unit and a data storage module, wherein the data processing system is able to acquire data, in particular images, from the optical detection devices in order to process the data and recognize the surgical instruments by comparing the acquired image with comparison images contained in a storage module;") ;
- acquiring at least one image which overall depicts said plurality of instruments by means of an optical detection device comprising a camera (Para. [0041]:"at least one optical detection device configured to acquire an image of the surgical instruments disposed on the support plane,");
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- processing said image by means of said processing unit to obtain the images of the single instruments (Abstract: "recognize each surgical instrument (12) by processing the acquired images (26).") and detect their outline (Para. [0089]:"The algorithms implemented in the data processing system 15 can be able to process the data and recognize the surgical instruments 12, for example by analyzing their characteristic parameters such as sizes, shape");
- recognizing by means of said processing unit the single instruments by comparing said processed images with the reference images of the single instruments stored in said recognition engine of said storage module for the recognition of said single instrument (Para. [0143]:"once the recognition of all the instruments 12 disposed on the support plane 21 has been completed with a positive outcome"; Abstract: "recognize each surgical instrument (12) by processing the acquired images (26)."), wherein said recognition has a positive outcome in the event that it can be at least partly overlapped with one of said reference images with a degree of confidence higher than a certain predefined threshold (Para. [0128]:"When the image detected substantially coincides with, or can be largely superimposed on, the corresponding image present in the database, the instrument 12 is identified and its presence in the kit 11 validated.");
- displaying on a user interface the outcome of said checking step and said recognition step (Para. [0130]:"a graphic indication of the failed recognition can be provided on the screen 16B.").
Tomarozzi does not show the comparing of the acquired image with reference images of the kit as recited in the third clause.
Sayani shows the determination whether any surgical instrument is missing on a surgical tray (kit) by capturing an image of the tray with a camera and analyzing the image with a computer (para. [0004]) and perform shape and location comparisons with pre-stored shapes of the surgical instruments (paras. [0037], [0038]).
Before the effective filing date of the claimed invention, it would have been obvious modify Tomarrozi to not only recognize individual surgical instruments, but expand its recognizing ability to determine if any surgical instrument is missing in images of surgical tray in order to determine the completeness of the surgical tray.
2. The method as in claim 1, comprising a preliminary training step for the creation of said recognition engine which, for each surgical instrument comprised in an operating kit, provides to acquire an image of a single instrument at a time (Para. [0041]:"a data processing system comprising a programmable central processing unit and a data storage module, wherein the data processing system is able to acquire data, in particular images, from the optical detection devices in order to process the data and recognize the surgical instruments by comparing the acquired image with comparison images contained in a storage module;").
4. The method as in claim 1, wherein said step of processing the image of a single instrument comprises processing by means of software selected from one or more HDR (High Dynamic Range) software, software comprising median filters, software comprising adaptive thresholds, canny edge detection software and software configured to perform morphological dilation and/or erosion operations to define an outline of the instrument (shape is an outline. para. [0126])
5. The method as in claim 1, comprising illuminating a base wall supporting said container by means of a light radiation, for a predetermined time interval during said step of acquiring said image (Para. [0143]: "highlighting it by means of a light signal"; See Fig. 2 of Sayani).
6. An apparatus for checking a kit of surgical instruments contained inside a container, wherein the apparatus comprises an optical detection device comprising a camera configured to detect an image of the kit of said instruments and a user interface for displaying the outcome of the check, the apparatus comprising a control and management unit comprising a processing unit and a storage module and operatively connected to said optical detection device and said interface of the apparatus wherein said storage module is configured as a recognition engine in which images of the kits of instruments to be checked are stored and reference images of the single instruments are stored and wherein said processing unit is configured to check whether all the instruments provided in the kit are present (Para. [0041]:"a data processing system comprising a programmable central processing unit and a data storage module, wherein the data processing system is able to acquire data, in particular images, from the optical detection devices in order to process the data and recognize the surgical instruments by comparing the acquired image with comparison images contained in a storage module;"), and whether they are in the intended position inside the container (see discussion of Sayani) by comparing the acquired image with said reference images of said kit stored in said storage module and is also configured to process the acquired image so as to obtain the images of the single instruments and detect their outline and to recognize the single instruments by comparing said processed images with the images stored in said recognition engine (see citation given for claim 4).
7. The apparatus as in claim 6, comprising a work chamber delimited at least by a base wall configured to receive said container restingly, by an upper wall parallel to said base wall, to which said optical detection device is associated, and by a connecting wall, which connects said base and upper walls and is perpendicular to the latter (see walls on 20a, 20b, 32 and base 21 in Fig. 1).
8. The apparatus as in claim 7, further comprising a pair of side walls connected both to said base wall and to said upper wall and to said connecting wall which is configured as a rear wall with respect to said work chamber (see walls on 20a, 20b, 32 and base 21 in Fig. 1).
9. The apparatus as in claim 7, comprising a front wall, parallel to said connecting wall and of lower extension than the latter to allow an operator to access said work chamber (see front wall of base 21 in Fig. 1).
10. The apparatus as in claims 8, comprising further optical detection devices (14, 22) also associated with said connecting wall and/or with said pair of side walls.
11. The apparatus as in claim 6, having the shape of a cube or of a parallelepiped with a square or rectangular base (Fig. 1).
12. The apparatus as in claim 6, comprising a lighting unit (22) associated with said upper wall to illuminate said base wall and comprising a LED lamp (Para. [0074]), configured to illuminate the base wall by means of homogeneous light radiation.
13. The apparatus as in claim 6, wherein said interface comprises augmented reality means intended to be worn by an operator which are configured to display information and receive instructions from said operator (Para. [0097]).
14. The apparatus as in claim 6, wherein said interface comprises an audio device able to acquire vocal instructions from said operator (Para. [0106]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tamarozzi and Sayani as applied to claim 1 above, and further in view of Simson et al. (US 2023/0117419).
Tamarozzi does not show the use of a neural network as a recognition engine and an audio device.
Simson shows the inspection of surgical kits using trained neural networks to compare captured images with trained images (para. [0054]) in order to whether each part is present or absent as well as if the part is defective.
Before the effective filing date of the claimed invention, it would have been obvious to use a neural network to perform the image comparison of Tamarozzi in order to improve the accuracy of image recognition.
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 Hwa Andrew S Lee whose telephone number is (571)272-2419. The examiner can normally be reached Mon-Fri 9am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michelle Iacoletti can be reached at (571) 270-5789. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Hwa Andrew Lee/Primary Examiner, Art Unit 2877
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