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 .
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,
optical detection device in claims 1-14, and
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 § 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 1-14 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 two separate distinct elements, a recognition engine and a processing unit, and it is unclear how they are distinct from each other. The processing unit is recited to perform the function of recognizing ("recognizing by means of said processing unit") and thus it is unclear how the two elements are distinct. Claims 2-14 are rejected for the same reason by virtue of their dependence on claim 1. For examination purposes, the recognition engine will be taken to be a collection of reference images.
For this reason the claims are also indefinite for failing to disclose the corresponding structure under 35 U.S.C. § 112(f). Claim limitation “recognition engine" and "processing unit” invoke 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 functions and to clearly link the structure, material, or acts to the functions. Therefore, the claims are indefinite and are 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.
Claim 11 is 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 11 recites the broad recitation "box-shaped", and the claim also recites "in particular the shape of a cube or of a pallelpiped with a square or rectangular base" which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In addition, the term "box-shaped" is indefinite because a box is not sufficiently defined as to what shape properties the box must have in order to be considered box-shaped. It is not clear if it must have six walls or if can have 4 walls, or if walls must be perpendicular to each other, etc. For examination purposes, the claim will be interpreted to be a shape having more than one wall.
Claims 4 and 5 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 4 recites two "and/or" in a single series of elements and it is unclear which combinations are grouped together by the "and" and which are alternatives by the "or." For examination purposes, the claim will be interpreted to recite every element as an alternative, i.e. an "or" before the last element.
Claim 5 recites the limitation " said base wall." There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the base wall will be interpreted to be a wall lower than another wall.
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) or Montano (US 2020/0143195).
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 said instruments and said kits and stored in a storage module of a control and management unit (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 (Para. [0041]:"at least one optical detection device configured to acquire an image of the surgical instruments disposed on the support plane,");
- checking by means of a processing unit of said control and management unit whether all the instruments provided in the kit are present (Para. [0143]:"once the recognition of all the instruments 12 disposed on the support plane 21 has been completed with a positive outcome"), and
- 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 shape (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 in said recognition engine for the recognition of said single instrument (Para. [0091]:"The recognition algorithms can for example be able to compare the data (that is, the images) with a database, for example created in a learning or initial set-up step of the method."; 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 shows analyzing characteristic parameters of the instruments such as sizes, shape, material and others, but does not show that position is one of the other parameters as recited in the third clause.
Sayani shows the detection of surgical instruments on a surgical tray where the location of the instruments is considered. Para. [0038]:". The structuring element here can be pre-stored shapes of the instruments 102, as stored in the database 110. The structuring element can be positioned at many or all possible locations in the image and it is compared with the corresponding neighborhood of pixels. Some operations test whether the element fits within the neighborhood, while others test whether it hits or intersects the neighborhood. A morphological operation on a binary image, such as the bitmap, can create a new binary image in which the pixel has a non-zero value only if the test is successful at that location in the input image."
Similarly, Montano shows where specific positions of each item of a collection is checked. Para. [0028].
Before the effective filing date of the claimed invention, it would have been obvious modify Tomarrozi to ascertain the position of the instruments as a parameter in order to determine the presence or absence of the instrument.
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 HDR (High Dynamic Range) software, software comprising median filters, adaptive thresholds, canny edge detection software and/or 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 said base wall 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 ").
6. An apparatus for checking a kit of surgical instruments contained inside a container, wherein the apparatus comprises an optical detection device 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 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 Montano and Sayani) by comparing the acquired image with said reference images of said kit 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 pparatus 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, being box-shaped, in particular the shape of a cube or of a parallelepiped with a square or rectangular base (Fig. 1 is box shaped).
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/Montano as applied to claim 1 above, and further in view of Simson et al. (US 2023/0117419).
Tamarozzi does not 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]).
Before the effective filing date of the claimed invention, it would have been obvious to use neural network to perform the image comparison of Tamarozzi in order to improve the accuracy of image recognition.
Conclusion
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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/Hwa Andrew Lee/ Primary Examiner, Art Unit 2877