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
In the preliminary amendment dated 19 September 2025, the following has occurred: Claims 5-9, 11, 13-15, 18-21, and 23-26 have been amended.
The present office action represents the first action on the merits.
Claims 1-26 are pending.
Priority
This application claims priority to PCT/EP2024/057589 dated 21 March 2024 and French application FR2302709 dated 22 March 2023.
Information Disclosure Statement
The information disclosure statement filed 19 September 2025 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because a copy of the translated abstract was not provided for IT201900012333. With the greatest of regrets, the Examiner does not speak or read Italian.
As noted on the signed IDS form accompanying this rejection, the remaining patent documents listed in the IDS have been fully considered by the Examiner. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Notice to Applicant
The Examiner notes that Claim 1 and its dependent claims are not currently subject matter eligible because the claim abstract concepts. The Examiner suggest reciting the physical steps/aspects recited in eligible Claim 16 and/or its dependents to overcome this rejection.
Claim Objections
Claims 1, 3, 4, 6-9, and 13 are objected to because they are missing an article before “object.” For instance, in Claim 1, the claim recites “tracking object” when it should recite “tracking an object” or, perhaps, “tracking objects.” Appropriate correction/clarification is required.
Claim 1 is objected to because it recites “in particular for anatomo-cytopathology ACP.” An acronym after a word/phrase should be within parentheses. Appropriate correction/clarification is required.
Claim 5 is objected to because it recites “The histopathological examination method according to claim 3 4, characterized…” The Examiner believes the “4” was intended to be struck-through and the claim has been examined as such. Appropriate correction/clarification is required.
Claim 7 recites “for counting the containers,” which lacks antecedent basis. Only one container was previously recited. The Examiner interprets the claim to require identifying at least one container.
Claim 13 is objected to because it recites “The histopathological examination method according to clam 1, characterized…” The Examiner believes “clam” should read “claim.” Appropriate correction/clarification is required.
Claim 16 recites “the method being characterised in that it comprises…the method comprising….” As a “comprising” transitional phrase was previously recited, these should read: the method being characterised in that it further comprises…the method further comprising…. Appropriate correction/clarification is required.
Claim 21 is similar to Claim 16, above, in that additional recitation of “comprising” after the initial transitional phrase should state “further comprises.” Appropriate correction/clarification is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(I) because the following figure(s) is/are unreadable and/or are unsatisfactory for reproduction:
Fig. 1-4 (figures will not reproduce well and there is unreadable text within the figures)
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 20, 21, and 26 recites “means for” language and are thus being interpreted under 112(f). The language includes:
Claim 20
means for identifying and tracking objects by analysing a video stream from at least one camera
Claim 21
means for identifying and tracking objects by analysing a video stream, these means being able to detect opening of the first container,
means for detecting and reading an identifier placed on the first container and an identifier placed on the second container,
means for generating an error message in the event of a discrepancy between the identifier of the first container and the identifier of the second container.
Claim 26
means for printing an identifier of the biological tissue on the block and on the slides.
Regarding Claims 20 and 21, the Examiner has reviewed the as-filed disclosure and finds that these “means for” correspond to a generic computer and/or attached barcode reader. Regarding Claim 26, Specification at Pg. 5, Lns. 12-17 describes the “means for printing an identifier” as being a known thermal printing system.
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.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claim recites a method for histopathological examination, which is within a statutory category.
Step 2A1
The limitations of: identifying and tracking object by analysing a video stream during a pre-analytical step and/or an analytical step for the biological tissues, as drafted, is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to perform analysis of a histopathological examination of biological tissues in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps of “identifying and tracking” as indicated supra.
The Examiner notes that the identified abstraction is not tied to any physical device and it thus purely directed to an abstract idea. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A2
There are no additional elements to analyze under step 2A2.
Step 2B
There are no additional elements to analyze under step 2B.
Claims 2-15 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
Claim(s) 2 merely describe(s) (optionally) preparing a request form or recording a collected sample, which further defines the abstract idea.
Claim(s) 2 also includes the additional element of “a laboratory management system” which generally links the “recording” abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) and MPEP 2106.05(A) indicate that merely “generally linking” the abstract idea to a particular technological environment or field of use cannot provide a practical application or significantly more.
Claim(s) 3 merely describe(s) labeling and reading, which further defines the abstract idea.
Claim(s) 4 merely describe(s) preparing a form, generating an identity, reading a form, and creating an alert, which further defines the abstract idea.
Claim(s) 5 merely describe(s) querying records, which further defines the abstract idea.
Claim(s) 6 merely describe(s) counting containers in a video stream and creating an alert, which further defines the abstract idea.
Claim(s) 7, 8 merely describe(s) counting containers in a video stream, which further defines the abstract idea.
Claim(s) 9, 13, 14 merely describe(s) identifying steps in a video stream, which further defines the abstract idea.
Claim(s) 10 merely describe(s) reading an identifier, which further defines the abstract idea.
Claim(s) 11 merely describe(s) generating information from a video, which further defines the abstract idea.
Claim(s) 12 merely describe(s) generating an alert when an alarm occurs in the video, which further defines the abstract idea.
Claim(s) 12 also includes the additional element of a “camera” which generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) and MPEP 2106.05(A) indicate that merely “generally linking” the abstract idea to a particular technological environment or field of use cannot provide a practical application or significantly more.
Claim(s) 15 merely describe(s) counting objects in a video and verifying correlation numbers, which further defines the abstract idea.
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 1-4, 6-16, 20, and 21 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 pre-AIA the applicant regards as the invention.
Claims 2 and 3 recite “labelling the biological tissues.” The claims are indefinite because it is unclear whether the actual tissue is labeled or whether a container containing the biological tissues is labeled. A review of the Specification at Pg. 26, Lns. 33-36 indicates that it is the container that is labeled and the Examiner suggests amending the claim as such.
Claims 3, 4, 6-9, 11, 13, 20, and 21 recite “analyzing a video stream.” The claim is indefinite because it is unclear whether this is the same video stream that was previously recited in Claim 1 or 16 or a different video stream. The Examiner assumes they are the same.
Claim 3 recites “characterised in that it comprises a step of labelling the biological tissues with generating a first patient identity….” The claim is unclear and thus indefinite for several reasons. First, the biological tissue was already labeled in Claim 2, thus it is unclear whether the biological tissue is labelled again for a second time or whether this is further defining the initial labeling. Second, the claim recites “a step of labeling…with generating…” which is indefinite because it is unclear whether the generating is required. Perhaps the Applicant meant “with a generated first patient identity?” It is also unclear because the claim states “a step” and then lists multiple steps rendering it unclear whether all the steps are required to occur. Third, the claim recites “identifying and tracking object by analysing a video stream comprising a step of reading this first patient identity.” As with the rejection directly above, it is unclear if the “identifying and tracking” is being performed again. It is also unclear because the claim states “a step” and then lists multiple steps rendering it unclear whether all the steps are required to occur.
Claim 4 recites “a step of preparing a histopathological examination request form generating a second patient identity.” The limitation is indefinite because it is unclear whether the generating is part of the preparing step or is a separate step. It is also unclear if the form is generating the 2nd identity or the user is. The claim further recites “a step of reading…a alert message being generated….” First, the Examiner notes that “generated” should be “generating” because this is a method claim. Thereafter, the limitation is unclear because the claim states “a step” and then lists multiple steps rendering it unclear whether all the steps are required to occur.
Claims 1, 3, 7, 9, and 16 recite “in particular” when referring to an item/step. The claims are indefinite because it is unclear whether the claim requires the item/step after “in particular.” This appears to be an optional element. As a matter of linguistic precision, optional claim elements do not narrow claim limitations since they can be omitted; “[c]laim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed.” MPEP 2111.04 & 2173.05(d) (see also In re Johnston, 435 F3d 1381, 77 USPQ2d 1788 (Fed Cir 2006)). The Examiner suggests deleting these features or positively reciting them.
Claim 7 recites “an alert message being generated when the volume of the preservative liquid is not adapted to the volume of the biological tissues.” The claim is indefinite because the claim requires “immersing the biological tissues…in a preservative liquid.” By definition, immersing means covering completely. The claim is indefinite because it is unclear how an alert message can be generated based on the claim. Alternately, or in addition, it is unclear (1) whether the alert message is generated while the biological tissue is being immersed in the liquid, i.e., generating the alarm until it is covered or (2) whether the alarm is generated after the immersion (or partial immersion) is complete.
Claim 8 recites “the containers,” which lacks antecedent basis.
Claim 10 recites “the cassette identifiers,” which lacks antecedent basis.
Claim 11 recites “making it possible to generate information comprising the duration of the dehydration cycle, the time remaining until the end of the dehydration.” The claim is indefinite because it is unclear whether the generation of “the duration of the dehydration cycle, the time remaining until the end of the dehydration” is required to occur; the generation is not positively recited. The Examiner interprets the claim to only require that the interface screen is displayed.
By virtue of their dependence from Claim 11, this basis of rejection also applies to dependent Claim 12.
Claim 12 recites “the camera,” which lacks antecedent basis.
Claim 13 recites “analysing the video stream being able to ensure counting of the biological tissues poured into the embedding mould.” The claim is indefinite because it is unclear whether the “counting of the biological tissues poured into the embedding mould” is required to occur; the counting is not positively recited. The Examiner interprets the claim to only require that the video is analyzed. The claim is also indefinite because it is unclear whether “such as paraffin” is limiting on the claim.
Claim 14 recites “selected from the group comprising macroscopic study steps.” The claim is indefinite because there is only one member of the group and it is unclear what the group is. This is an improper Markush group.
Claim 15 recites “the stained slides,” which lacks antecedent basis. The claim is also indefinite because it is unclear whether “allowing counting of the collected samples present on the stained slides, from a cassette, and a step of verifying correlation of this number with the number of collected samples present in the cassette” is required to occur. The only thing that is positively recited in the claim is analyzing video. That the analyzed video allows something further to happen appears to be immaterial. The claim has been analyzed assuming that only analyzing the video is required. The Examiner suggests positively reciting the features after “allowing.”
Claim 21 recites a “device, for implementing a method according to claim 16,…the device comprising means for identifying and tracking objects by analysing a video stream, these means being able to detect opening of the first container, the device comprising means for detecting and reading an identifier placed on the first container and an identifier placed on the second container, the device comprising means for generating an error message in the event of a discrepancy between the identifier of the first container and the identifier of the second container.” Claim 16 recites all the functionality performed by the “means for” (i.e., tracking and tracking, detecting and reading, and generating). The claim is indefinite because it is unclear whether the functions of the “means for” are meant to further define the steps of Claim 16 or to replace them. Per the 112(f) interpretation, supra, the Examiner interprets Claim 21 to require that the noted steps are performed on a computer. The Examiner suggests reciting, for example, “means for performing the detecting and reading of an identifier placed on the first container and an identifier placed on the second container.”
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. §§ 102 and 103 (or as subject to pre-AIA 35 U.S.C. §§ 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 of this title, 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, 9, 14-18, and 20 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Rapuano et al. (WIPO Publication No. WO2022/266459).
REGARDING CLAIM 1
Rapuano teaches the claimed method for histopathologically examining biological tissues, especially surgical specimen or biopsy, in particular for anatomo-cytopathology ACP, characterised in that it comprises
identifying and tracking object by analysing a video stream during a pre-analytical step and/or an analytical step for the biological tissues. [Para. 0058 teaches that a camera takes video of the labeling and movement of a biopsy and its identifying label information from a sample container to a cassette and that the data is analyzed by a CPU. This is done prior to analysis (pre-analytical). The Examiner interprets a biopsy to be comprised of “tissues” as indicated in the preamble.]
To the extent that the disclosure of Rapuano represents different embodiments of the disclosed invention, it would have been prima facie obvious to one of ordinary skill in the art of healthcare, at the time of filing, to modify the biopsy handling and tracking features of Rapuano with any of the other features disclosed by Rapuano, with the motivation of improving the handling, tracking, and analysis of patient tissue/biopsy samples.
REGARDING CLAIM 2
Rapuano teaches the claimed method of Claim 1. Rapuano further teaches
characterised in that the pre-analytical step is selected from the group comprising
collecting biological tissues from the operating field, [Para. 0054 teaches that a biopsy is collected. Anywhere a biopsy is collected is interpreted as an operating field.]
orienting the biological tissues,
labelling the biological tissues collected, [Para. 0054 teaches that the sample (in a bottle) is labeled.]
placing the tissues in a container in a fresh state, [Para. 0054 teaches placing the biopsy in a sample bottle.]
immersing the biological tissues collected in a preservative liquid such as a fixing agent, [Para. 0054 teaches that the bottle contains a fixative, thus the biopsy is immersed.]
preparing a histopathological examination request form,
transporting the collected sample to a recording station, [Para. 0054 teaches that the bottled biopsy is transferred (transported) to a pathology laboratory (interpreted t contain a recording station).]
recording the collected sample in a laboratory management system. [Para. 0056 teaches that biopsy label information is entered into a computer database (a laboratory management system).]
The Examiner notes that should the claim be amended such that the actual tissue is labeled (see 112(b) rejection, supra), AAPA would be cited as teaching that this was known in the art.
REGARDING CLAIM 9
Rapuano teaches the claimed method of Claim 1. Rapuano further teaches
characterised in that it comprises identifying and tracking object by analysing a video stream during a step of preparing biological tissues selected from the group comprising [Para. 0058 teaches that a camera takes video of the labeling and movement of a biopsy and its identifying label information from a sample container to a cassette.]
dehydrating,
embedding in a material, in particular paraffin,
cutting in particular with a cryostat or microtome to form ribbons,
spreading the ribbons on supports such as glass slides,
dispensing. [Para. 0058 teaches that the sample is transferred (dispensed) from the sample container to the cassette.]
REGARDING CLAIM 14
Rapuano teaches the claimed method of Claim 1. Rapuano further teaches
characterised in that the analytical step is selected from the group comprising macroscopic study steps. [Para. 0058 teaches that a camera takes video of the movement of the biopsy specimen and further teaches that the biopsy information is used to determine size, color and number of particles in the specimen (macroscopic study steps, which are undefined).]
REGARDING CLAIM 15
Rapuano teaches the claimed method of Claim 1. Rapuano further teaches
characterised in that it comprises analysing the video streams [Para. 0058 teaches that the video data is analyzed.] allowing counting of the collected samples present on the stained slides, from a cassette, and a step of verifying correlation of this number with the number of collected samples present in the cassette. [The Examiner notes that, per the 112(b) rejection, supra, the “allowing” portion of the claim is not required to occur and is thus not addressed.]
REGARDING CLAIM 16
Rapuano teaches the claimed method for histopathological examination, in particular natomopathology examination, comprising
a step of introducing a tissue into a first container provided with a closure means, [Para. 0054 teaches that a biopsy sample (tissue) is placed into a labeled sample bottle.]
a step of closing the first container after introducing the tissue, [Para. 0054, 0056 teaches that the sample bottle is transported to a pathology laboratory. Fig. 1C, item 106 teaches that the sample bottle has a lid, meaning it is closed. As is known in the art, pathology sample bottles include a lid which is closed prior to transporting the sample bottle. Para. 0017 teaches that the sample container is sealed (closed).]
a step of placing on the first container an identifier of the tissue introduced into the first container, [Para. 0054 teaches that the sample bottle is labeled with patient and sample information (an identifier).]
a step of opening the first container and extracting the tissue from the first container, [Para. 0056 teaches transferring the biopsy from the sample bottle. Fig. 1B, 1C, Para. 0059 teaches that the lid is removed from the bottle.]
a step of moving at least one part of the tissue extracted from the first container into a second container, the second container bearing an identifier of the part of the tissue, [Para. 0056 teaches that the biopsy is transferred to an identically labeled cassette.]
the method being characterised in that it comprises
identifying and tracking objects by analysing a video stream, [Para. 0058 teaches that a camera takes video of the labeling and movement of a biopsy and its identifying label information from a sample container to a cassette and that the data is analyzed by a CPU.]
opening of the first container being detected during this identification and tracking of objects, [Para. 0058 teaches that the movements of the biopsy are tracked via video. Fig. 1B, 1C teaches that the bottle is opened as part of the transfer of the biopsy to the cassette.]
the method comprising
a step of detecting and reading the identifier placed on the first container and the identifier placed on the second container, [Para. 0059 teaches that the sample container label is scanned. Para. 0061, 0077, 0078 teaches that the cassette is labeled and scanned.]
an error message being generated in the event of a discrepancy between the identifier of the first container and the identifier of the second container. [Para. 0079 teaches that a sample error alarm is provided when there is an error in the labeling information between the sample container and the corresponding labeled sample cassette.]
REGARDING CLAIM 17
Rapuano teaches the claimed method of Claim 16. Rapuano further teaches
characterised in that it comprises a step of recording the instant at which opening of the first container is detected. [Para. 0058 teaches that a camera takes video of the labeling and movement of a biopsy and its identifying label information from a sample container to a cassette and that the data is analyzed by a CPU. This necessarily means that the video includes the instant at which the sample container is opened.]
REGARDING CLAIM 18
Rapuano teaches the claimed method of Claim 16. Rapuano further teaches
characterised in that the second container is a cassette, [Para. 0058 teaches a cassette.]
closing the cassette and closing the first container being detected by identifying and tracking objects when analysing the video stream. [Fig. 1C, item 106 teaches that the sample bottle has a lid, meaning it is closed. Para. 0017 teaches that the sample container is sealed (closed). Para. 0059 teaches that the cassette is also closed. Para. 0058 teaches that a camera takes video of the labeling and movement of a biopsy and its identifying label information from a sample container to a cassette and that the data is analyzed by a CPU. This necessarily means that the video includes the closing of the sample container and cassette.]
REGARDING CLAIM 20
Rapuano the claimed device for implementing a method according to Claim 1
the device being characterised in that it comprises means for identifying and tracking objects by analysing a video stream from at least one camera. [Para. 0004, 0058 teaches a CPU that performed the biopsy tracking functionality and that the video is from a camera. See Claim 1 for further citations.]
Claim(s) 3, 5, 7, 8, 10, and 19 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Rapuano et al. (WIPO Publication No. WO2022/266459) in view of Spong et al. (U.S. Pre-Grant Patent Publication No. 2020/0233000).
REGARDING CLAIM 3
Rapuano teaches the claimed method of Claims 1 and 2. Rapuano further teaches
characterised in that it comprises
a step of labelling the biological tissues with generating a first patient identity, in alphanumeric form or coded form, in particular by barcode, [Para. 0056, 0065 teaches that sample bottles are labeled with patient information such as a patient’s name (a first patient identity), which has necessarily been generated. The Examiner interprets the patient name to be in alphanumeric form.]
The Examiner notes that should the claim be amended such that the actual tissue is labeled (see 112(b) rejection, supra), AAPA would be cited as teaching that this was known in the art.
Rapuano may not explicitly teach
identifying and tracking object by analysing a video stream comprising a step of reading this first patient identity, in particular reading a barcode.
Spong at Para. 0060,0067, 0072, 0075 teaches that it was known in the art of laboratory workflows, at the time of filing, to extract an identifier from a sample container label from video images
identifying and tracking object by analysing a video stream comprising a step of reading this first patient identity, in particular reading a barcode. [Spong at Para. Para. 0060, 0075 teaches that a camera takes images of a sample label and extracts a patient identifier from it, thus tracking the sample container. Spong at Para. 0045, 0054 teaches that the image data may be video. Spong at Para. 0072 teaches tracking process steps via capturing image data (video feed, see Para. 0067).]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of laboratory workflows, at the time of filing, to modify the biopsy handling and tracking features of Rapuano to extract an identifier from a sample container label from video images as taught by Spong, with the motivation of improving the accuracy and precision of laboratory workflows (see Spong at Para. 0003).
REGARDING CLAIM 5
Rapuano/Spong teaches the claimed method of Claims 1-3. Rapuano/Spong further teaches
characterised in that it comprises
a step of querying the computerised patient record and [Spong at Para. 0069 teaches that data is compared to data in the patient’s electronic medical record, thus the EMR is queried.]
a step of collecting information elements contained in the computerised patient record, [Spong at Para. 0069 teaches that the patient’s EMR data is used, thus it is collected.] for copying into a histopathological examination request form generated in digital form. [The Examiner notes that “for copying…” is an intended use of the collected elements and is not required to occur.]
The Examiner notes that should the “for copying…” feature be made to be required to be performed, Eberting at Para. 0148 appears to teach this.
REGARDING CLAIM 7
Rapuano teaches the claimed method of Claim 1. Rapuano may not explicitly teach
characterised in that it comprises a check step carried out in a buffer zone in which a plurality of collected samples of biological tissues, in particular from different operating rooms of an operating theatre, are gathered, the method comprising identifying and tracking object by analysing a video stream for counting the containers placed in the buffer zone.
Spong at Para. 0060,0067, 0072, 0075 teaches that it was known in the art of laboratory workflows, at the time of filing, to utilize video to extract an identifier from sample containers containing specimens that are within a staging area
characterised in that it comprises a check step carried out in a buffer zone in which a plurality of collected samples of biological tissues, in particular from different operating rooms of an operating theatre, are gathered, the method comprising identifying and tracking object by analysing a video stream for counting the containers placed in the buffer zone. [Spong at Para. 0060 teaches a staging area (a buffer zone) where cameras create a visual record of tissue specimens and containers. The Examiner notes that “for counting…” is an intended use of the recorded data.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of laboratory workflows, at the time of filing, to modify the biopsy handling and tracking features of Rapuano to utilize video to extract an identifier from sample containers containing specimens that are within a staging area as taught by Spong, with the motivation of improving the accuracy and precision of laboratory workflows (see Spong at Para. 0003).
REGARDING CLAIM 8
Rapuano teaches the claimed method of Claim 1. Rapuano may not explicitly teach
characterised in that it comprises identifying and tracking object by analysing a video stream when recording of a collected sample in a laboratory management system, for counting the containers and/or checking suitability of the fixing agent volume for the collected sample placed in a container.
Spong at Para. 0060,0067, 0072, 0075 teaches that it was known in the art of laboratory workflows, at the time of filing, to extract an identifier from a sample container label from video images
characterised in that it comprises identifying and tracking object by analysing a video stream when recording of a collected sample in a laboratory management system, for counting the containers and/or checking suitability of the fixing agent volume for the collected sample placed in a container. [Spong at Para. Para. 0060, 0075 teaches that a camera takes images of a sample label and extracts a patient identifier from it, thus tracking the sample container. Spong at Para. 0045, 0054 teaches that the image data may be video. Spong at Para. 0072 teaches tracking process steps via capturing image data (video feed, see Para. 0067).]
The Examiner notes that “for counting the containers and/or checking suitability” is an intended use of the video stream analysis that is not required to occur.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of laboratory workflows, at the time of filing, to modify the biopsy handling and tracking features of Rapuano to extract an identifier from a sample container label from video images as taught by Spong, with the motivation of improving the accuracy and precision of laboratory workflows (see Spong at Para. 0003).
REGARDING CLAIM 10
Rapuano teaches the claimed method of Claims 1 and 9. Rapuano may not explicitly teach
characterised in that it comprises reading the entirety of the cassette identifiers, these identifiers being alphanumeric or coded, especially in a barcode.
Spong at Para. 0060,0067, 0072, 0075 teaches that it was known in the art of laboratory workflows, at the time of filing, to take an image of identifying data on a cassette and analyze text data on a label
characterised in that it comprises reading the entirety of the cassette identifiers, these identifiers being alphanumeric or coded, especially in a barcode. [Spong at Para. 0060 teaches cameras take images of the labeling on a cassette. Spng at Para. 0075, 0076 teaches that the text on a cassette label is analyzed, meaning it is read.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of laboratory workflows, at the time of filing, to modify the biopsy handling and tracking features of Rapuano to take an image of identifying data on a cassette and analyze text data on a label as taught by Spong, with the motivation of improving the accuracy and precision of laboratory workflows (see Spong at Para. 0003).
REGARDING CLAIM 19
Rapuano teaches the claimed method of Claim 16. Rapuano may not explicitly teach
characterised in that displaying the objects identified when analysing the video stream is carried out, the shape of the objects identified being represented by a bounding window.
Spong at Para. 0060,0067, 0072, 0075 teaches that it was known in the art of laboratory workflows, at the time of filing, to display imaging of a sample where the imaging is displayed within a box
characterised in that displaying the objects identified when analysing the video stream is carried out, the shape of the objects identified being represented by a bounding window. [Spong at Fig. 10, Para. 0080 teaches displaying analyzed imaging (the video of Rapuano). Spong at Para. 0045, 0054 teaches that the image data may be video. Spong at Fig. 10 teaches that the image represents the sample of the sample and is surrounded by a box (a bounding box, which is undefined).]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of laboratory workflows, at the time of filing, to modify the biopsy handling and tracking features of Rapuano to display imaging of a sample where the imaging is displayed within a box as taught by Spong, with the motivation of improving the accuracy and precision of laboratory workflows (see Spong at Para. 0003).
Claim(s) 4 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Rapuano et al. (WIPO Publication No. WO2022/266459) in view of Spong et al. (U.S. Pre-Grant Patent Publication No. 2020/0233000) in view of Eberting et al. (U.S. Pre-Grant Patent Publication No. 2017/0329922).
REGARDING CLAIM 4
Rapuano/Spong teaches the claimed method of Claims 1-3. Rapuano/Spong further teaches
characterised in that it comprises
[…],
identifying and tracking object by analysing a video stream comprising a step of reading this examination request form and the second patient identity, [Spong at Para. 0060, 0075 teaches performing a QA analysis of image data taken by a camera of a sample label and associated requisition document. Spong at Para. 0045, 0054 teaches that the image data may be video. Text from the sample label and the document contained in images, such as patient name, is analyzed to determine if the items are associated with the correct patient.]
an alert message being generated in the event of a discrepancy between the first and the second patient identity. [Spong at Para. 0079 teaches that if the patient name data is not consistent, the system will prompt the user to take corrective action (an alert). The Examiner interprets the patient identifier on the sample as a first patient identity and the patient identifier on the document as the second patient identity, which appears to be consistent with the claim.]
Rapuano/Spong may not explicitly teach
a step of preparing a histopathological examination request form generating a second patient identity,
Eberting at Para. 0148, 0152, 0159, 0160 teaches that it was known in the art of computerized healthcare, at the time of filing, to populating an order requisition with patient identification information
a step of preparing a histopathological examination request form generating a second patient identity, [Eberting at Para. 0148 teaches populating (preparing) an order requisition with patient identification information. See also Para. 0152, 0159. Para. 0160 teaches that the order requisition can be printed and taken to the specimen collection site. The requisition is interpreted as the document of Spong.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of laboratory workflows, at the time of filing, to modify the biopsy handling and tracking features of Rapuano having the extraction of an identifier from a sample container label from video images of Spong to populating an order requisition with patient identification information as taught by Eberting, with the motivation of improving the accuracy of form population.
Claim(s) 6 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Rapuano et al. (WIPO Publication No. WO2022/266459) in view of Spong et al. (U.S. Pre-Grant Patent Publication No. 2020/0233000) in view of Boege et al. (WIPO Publication No. WO2022/023481).
REGARDING CLAIM 6
As best understood by the Examiner, Rapuano/Spong teaches the claimed method of Claim 1. Rapuano/Spong further teaches
characterised in that it comprises
identifying and tracking object by analysing a video stream when immersing the biological tissues such as a surgical specimen in a preservative liquid such as a fixing agent, […]. [Rapuano at Para. 0054 teaches that the biopsy is placed into a bottle containing a fixative, thus the biopsy is immersed. Spong at Para. 0072 teaches tracking process steps via capturing image data (video feed, see Para. 0067).]
Rapuano/Spong may not explicitly teach
an alert message being generated when the volume of the preservative liquid is not adapted to the volume of the biological tissues.
Boege at Para. 0010, 0032, 0066, 0067, 0059, 0103 teaches that it was known in the art of laboratory workflows, at the time of filing, to create an alert when a container having a tissue specimen therein is not filled completely with a reagent
an alert message being generated when the volume of the preservative liquid is not adapted to the volume of the biological tissues. [Boege at Para. 0010, 0059 teaches taking a subject’s sample utilizing and determining parameters such as filling volume of the sample container (volume of the preservative). Para. 0032 teaches that a parameter values that falls short of a predetermined threshold results in an automatic alert. Para. 0066, 0067 teaches that the sample container is a biopsy collection tube containing a tissue sample and that the fluid is a stabilizing reagent. Para. 0103 teaches that the volume is determined using a camera (the video of Rapuano/Spong).]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of laboratory workflows, at the time of filing, to modify the biopsy handling and tracking features of Rapuano having the extraction of an identifier from a sample container label from video images of Spong t to create an alert when a container having a tissue specimen therein is not filled completely with a reagent as taught by Boege, with the motivation of reducing errors and improving quality indicators (see Boege at Para. 0007).
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Rapuano et al. (WIPO Publication No. WO2022/266459) in view of Heydlauf (U.S. Pre-Grant Patent Publication No. 2014/0152820).
REGARDING CLAIM 11
Rapuano teaches the claimed method of Claims 1 and 9. Rapuano may not explicitly teach
characterised in that at least one interface screen of a dehydration machine is filmed, an analysis of a video stream making it possible to generate information comprising the duration of the dehydration cycle, the time remaining until the end of the dehydration.
Heydlauf at Para. 0005, 0051, 0052, 0066 teaches that it was known in the art of laboratory data processing, at the time of filing, to monitor the display of a laboratory device
characterised in that at least one interface screen of a dehydration machine is filmed, an analysis of a video stream making it possible to generate information comprising the duration of the dehydration cycle, the time remaining until the end of the dehydration. [Heydlauf at Para. 0005, 0051, 0052, 0066 teaches monitoring laboratory devices by streaming images of a monitor screen of a controller (an interface screen; interpreted as “filmed”) onto a display screen of a remote monitoring unit and detecting changes in the images (analyzing the images). This makes “it possible to generate information comprising the duration of the dehydration cycle, the time remaining until the end of the dehydration. Heydlauf at Para. 0039 teaches that the laboratory device is an Immulite 2500, which has a dehydration feature, as is known in the art.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of laboratory workflows, at the time of filing, to modify the biopsy handling and tracking features of Rapuano to monitor the display of a laboratory device as taught by Heydlauf, with the motivation of improving the efficiency, safety, and quality of laboratory systems (see Heydlauf at Para. 0004).
REGARDING CLAIM 12
Rapuano/Heydlauf teaches the claimed method of Claims 1, 9, and 11. Rapuano/Heydlauf further teaches
characterised in that it comprises a step of generating an alert message, when an operation alarm has been detected for the dehydration machine, when analysing the video stream from the camera filming the interface screen of the dehydration machine. [Heylauf at Fig. 5, left panel, Para. 0055 teaches that flag management creates an event flag (an alert message) to notify the remote user of a mechanical issue with the laboratory device. Per the 112(b) rejection, supra, there is no camera and thus this is interpreted as non-functional information.]
Claim(s) 13 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Rapuano et al. (WIPO Publication No. WO2022/266459) in view of Williamson et al. (European Patent Application Publication No. EP2259042).
REGARDING CLAIM 13
Rapuano teaches the claimed method of Claim 1. Rapuano further teaches
characterised in that it comprises identifying and tracking object by analysing a video stream during […biological tissue analysis…], analysing the video stream being able to ensure counting of the biological tissues […] poured into the embedding mould. [Para. 0058, 0059 teaches that a camera takes video of the movement of a biopsy into a cassette and then into a formalin repository (an embedding material). Para. 0058, 0062 teaches that the video data is analyzed to determine the number of pieces of a biopsy sample in a location.]
Rapuano may not explicitly teach
a step of embedding biological tissues in an embedding material such as paraffin, […] biological tissues poured into the embedding mould
Williamson at Fig. 10, Para. 0098, 0099 teaches that it was known in the art of biopsy analysis, at the time of filing, to embed a biopsy in a mold using paraffin and videoing the number of tissue pieces
a step of embedding biological tissues in an embedding material such as paraffin, […] biological tissues poured into the embedding mould [Williamson at Para. 0052, 0075, 0090 et seq. teaches embedding tissue samples in paraffin in a mold cavity (the location of Rapuano). Williamson at Para. 0075 teaches taking a video of the number of tissue pieces in a cassette cavity (a mold).]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of laboratory workflows, at the time of filing, to modify the biopsy handling and tracking features of Rapuano to embed a biopsy in a mold using paraffin and videoing the number of tissue pieces as taught by Williamson, with the motivation of improving laboratory workflow and providing results in a more timely manner (see Williamson at Para. 0041).
Claim(s) 21 and 23 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Applicant Admitted Prior Art (“AAPA”) in view of Rapuano et al. (WIPO Publication No. WO2022/266459).
REGARDING CLAIM 21
AAPA teaches the claimed anatomopathology device, for implementing a method according to claim 16, the device including
a workstation [AAPA at Pg. 2, Lns. 23-24 teaches a workstation.] comprising
a cutting board [AAPA at Pg. 2, Lns. 23-24 teaches a dissecting board (cutting board).] for supporting a first container provided with a closure means and a second container, [The Examiner notes that “for supporting” is an intended use and is not required to occur, though logic would dictate that any even somewhat horizontal surface would meet this.]
AAPA may not explicitly teach
the device comprising means for identifying and tracking objects by analysing a video stream, these means being able to detect opening of the first container,
the device comprising means for detecting and reading an identifier placed on the first container and an identifier placed on the second container,
the device comprising means for generating an error message in the event of a discrepancy between the identifier of the first container and the identifier of the second container.
Rapuano at Para. 0004, 0058 teaches that is was known in the art of laboratory workflow analysis, at the time of filing, to provide a CPU that analyzes laboratory biopsy tracking video
the device comprising means for identifying and tracking objects by analysing a video stream, these means being able to detect opening of the first container, [Rapuano at Para. 0004, 0058 teaches a CPU that performed the biopsy tracking functionality and that the video is from a camera. See Claim 16 for further citations.]
the device comprising means for detecting and reading an identifier placed on the first container and an identifier placed on the second container, [Rapuano at Para. 0004, 0058 teaches a CPU that performed the biopsy tracking functionality and that the video is from a camera. See Claim 16 for further citations.]
the device comprising means for generating an error message in the event of a discrepancy between the identifier of the first container and the identifier of the second container. [Rapuano at Para. 0004, 0058 teaches a CPU that performed the biopsy tracking functionality and that the video is from a camera. See Claim 16 for further citations.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of laboratory workflows, at the time of filing, to modify the laboratory workstation of AAPA to provide a CPU that analyzes laboratory biopsy tracking video as taught by Rapuano, with the motivation of decreasing the risk of errors (see AAPA at Pg. 3,4).
REGARDING CLAIM 23
AAPA/Rapuano teaches the claimed anatomopathology device, for implementing a method according to claim 16 of Claim 21. AAPA/Rapuano further teaches
characterised in that the detection and reading means comprise a one- or two- dimensional barcode reader. [Rapuano at Para. 0011, 0065, 0077 teaches that the system can read a barcode (a one-dimensional code) or a QR code (a two-dimensional code).]
Claim(s) 22, 25, and 26 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Applicant Admitted Prior Art (“AAPA”) in view of Rapuano et al. (WIPO Publication No. WO2022/266459) in view of Williamson et al. (European Patent Application Publication No. EP2259042).
REGARDING CLAIM 22
AAPA/Rapuano teaches the claimed anatomopathology device, for implementing a method according to claim 16 of Claim 21. AAPA/Rapuano may not explicitly teach
characterised in that the cutting board comprises a recess capable of housing a first or second container, the first container preferably being a vial, the second container preferably being a cassette.
Williamson at Fig. 10, Para. 0098, 0099 teaches that it was known in the art of biopsy analysis, at the time of filing, to provide a workstation with a biopsy container storage
characterised in that the cutting board comprises a recess capable of housing a first or second container, the first container preferably being a vial, the second container preferably being a cassette. [Williamson at Fig. 10, Para. 0098, 0099 teaches a biopsy workstation (the flat portion of which is interpreted as a cutting/disection board; the cutting board of AAPA) having a storage location for biopsy containers (the sample container of Rapuano). Williamson at Para. 0024, 0054 also teaches a tissue sectioning support (also a cutting/disection board; the cutting board of AAPA).]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of laboratory workflows, at the time of filing, to modify the laboratory workstation of AAPA having the CPU that analyzes laboratory biopsy tracking video of Rapuano to provide a workstation with a biopsy container storage as taught by Williamson, with the motivation of improving laboratory workflow and providing results in a more timely manner (see Williamson at Para. 0041).
REGARDING CLAIM 25
AAPA/Rapuano teaches the claimed anatomopathology device, for implementing a method according to claim 16 of Claim 21. AAPA/Rapuano may not explicitly teach
characterised in that the workstation comprises measuring means along several axes.
Williamson at Para. 0075 teaches that it was known in the art of biopsy analysis, at the time of filing, to provide a workstation with a grid reticule that is used for sample size calibration
characterised in that the workstation comprises measuring means along several axes. [Williamson at Para. 0075 teaches a grid reticule that is used for sample size calibration having a 1mm graduation. A gird is multiple axes.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of laboratory workflows, at the time of filing, to modify the laboratory workstation of AAPA having the CPU that analyzes laboratory biopsy tracking video of Rapuano to provide a workstation with a biopsy container storage as taught by Williamson, with the motivation of improving laboratory workflow and providing results in a more timely manner (see Williamson at Para. 0041).
REGARDING CLAIM 26
AAPA/Rapuano teaches the claimed anatomopathology device, for implementing a method according to claim 16 of Claim 21. AAPA/Rapuano further teaches
the device comprising means for printing an identifier of the biological tissue on the block and on the slides. [AAPA at Pg. 6, Lns. 12-14 teaches a thermal printing system.]
AAPA/Rapuano may not explicitly teach
characterised in that it comprises a biological tissue embedding station to form a block, a station for cutting the block into thin slices with a microtome, and a station for spreading the slices on slides, […].
Williamson at Fig. 10, Para. 0020, 0027 teaches that it was known in the art of biopsy analysis, at the time of filing, to provide an embedding station that forms a block, cuts the block, and places the cuts on a slide
characterised in that it comprises a biological tissue embedding station to form a block, [Williamson at Fig. 10, Para. 0020 teaches a station that embeds tissue into a block.]
a station for cutting the block into thin slices with a microtome, and [Williamson at Fig. 10, Para. 0020 teaches a station that slices the block with a microtome into thin slices.]
a station for spreading the slices on slides, […]. [Williamson at Fig. 10, Para. 0027 teaches a station that mounts microtome sections (i.e., the slices) on a slide.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of laboratory workflows, at the time of filing, to modify the laboratory workstation of AAPA having the CPU that analyzes laboratory biopsy tracking video of Rapuano to provide a workstation with a biopsy container storage as taught by Williamson, with the motivation of improving laboratory workflow and providing results in a more timely manner (see Williamson at Para. 0041).
Claim(s) 24 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Applicant Admitted Prior Art (“AAPA”) in view of Rapuano et al. (WIPO Publication No. WO2022/266459) in view of Luchinger et al. (U.S. Pre-Grant Patent Publication No. 2011/0286886).
REGARDING CLAIM 24
AAPA/Rapuano teaches the claimed anatomopathology device, for implementing a method according to claim 16 of Claim 21. AAPA/Rapuano may not explicitly teach
characterised in that the workstation comprises weighing means.
However, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to combine the laboratory instrument having a weighing cell of Luchinger
with teaching of AAPA/Rapuano since the combination of the references is merely combining prior art elements according to known methods to yield predictable results (KSR rationale A). It can be seen that each element claimed is present in either AAPA/Rapuano or Luchinger. Providing a laboratory weighing cell (as taught by Luchinger at Para. 0034) does not change or affect the normal laboratory system of AAPA/Rapuano. Performing laboratory analysis of patient biopsy samples via a laboratory system would be performed the same way even with the addition of a laboratory weighing cell. Since the functionalities of the elements in AAPA/Rapuano and Luchinger do not interfere with each other, the results of the combination would be predictable.
Conclusion
Prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Leboudec (U.S. Pre-Grant Patent Publication No. 2021/0025906) which discloses a control program for laboratory automation device that tracks manual pipet use via video and creates a program therefrom for robotic pipet use.
Suter et al. (U.S. Pre-Grant Patent Publication No. 2021/0304886) which discloses using an image sensor and augmented reality to track resources within a laboratory.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON S TIEDEMAN whose telephone number is (571)272-4594. The examiner can normally be reached 7:00am-4:00pm, off alternate Fridays.
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/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683