DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . This application has been examined. Claims 1-25 are pending in this application.
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 co
2. Claim(s) 1-25 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The limitations, under their broadest reasonable interpretation, cover mental process (concept performed in a human mind, including as observation, evaluation, judgment, opinion, organizing human activity and mathematical concepts and calculations). The independent claim(s) recite(s) a system or method for monitoring pharmaceutical operations. This judicial exception is not integrated into a practical application because the steps do not add meaningful limitations to be considered specifically applied to a particular technological problem to be solved .The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps of the claimed invention can be done mentally and no additional features in the claims would preclude them from being performed as such except for the generic computer elements at high level of generality (i.e., processor, memory).
According to the USPTO guidelines, a claim is directed to non-statutory subject matter if:
STEP 1: the claims do not fall within one of the four statutory categories of invention (process, machine, manufacture or composition of matter), or
STEP 2: the claim recites a judicial exception, e.g. an abstract idea, without reciting additional elements that amount to significantly more than the judicial exception, as determined using the following analysis:
STEP 2A (PRONG 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
STEP 2A (PRONG 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
STEP 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
Using the two-step inquiry, it is clear that independent claims 1-9 are directed to an abstract idea as shown below:
STEP 1: Do the claims fall within one of the statutory categories? YES. Claim(s) 1-25 are directed to a system and method, i.e. a device and method system, respectively.
STEP 2A (PRONG 1): Is the claim directed to a law of nature, a natural phenomenon or an abstract idea? YES , the claims are directed toward a mental process (i.e. abstract idea).
With regard to STEP 2A (PRONG 1), the guidelines provide three groupings of subject matter that are considered abstract ideas:
Mathematical concepts – mathematical relationships, mathematical formulas or equations, mathematical calculations;
Certain methods of organizing human activity – fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions); and
Mental processes – concepts that are practicably performed in the human mind (including an observation, evaluation, judgment, opinion).
The system in claim 1 (and the method in claim 25 ) comprise a mental process that can be practicably performed in the human mind (or generic computers or components configured to perform the method and system), therefore, an abstract idea.
Claim(s) 1 and 25, the system and method recites the steps (or functions) of:
enclosure defining an interior space, at least one camera installed so as to record image frames of the interior space (recite genetic components that can be used to take a picture inside a space), and a controller, wherein the controller is configured to: receive the image frames recorded by the at least one camera (recite genetic components that can be used to take a picture inside a space), analyze the image frames to detect an event captured by one or more of the image frames using a first model, perform a classification of an intervention captured by one or more of the image frames using a second model (the analyzing recites a mental process including observation and evaluation, the first model and second model could be observation and analyze of the captured image or event from different areas, that can be done mentally in the human mind; similar to observe and recognize an image on a gas station sign for example), the second model being trained with image frames of interventions assigned to at least two different classes, and provide a notification indicating one of the at least two different classes based on the classification (the training recites a mental process including observation and evaluation different images having different classes as drawings or text, the second model could be an observation of the captured image or event from different areas, that can be done mentally in the human mind; similar to observe and recognize an image on a gas station sign for example).
These limitations, as drafted, is a simple process that, under their broadest reasonable interpretation, covers performance of the limitations in the mind or by a human. The Examiner notes that under MPEP 2106.04(a)(2)(III), the courts consider a mental process (thinking) that “can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). As the Federal Circuit explained, "methods which can be performed mentally, or which are the equivalent of human mental work, are unpatentable abstract ideas the ‘basic tools of scientific and technological work’ that are open to all.’" 654 F.3d at 1371, 99 USPQ2d at 1694 (citing Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972)). See also Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 ("‘[M]ental processes[] and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work’" (quoting Benson, 409 U.S. at 67, 175 USPQ at 675)); Parker v. Flook, 437 U.S. 584, 589, 198 USPQ 193, 197 (1978) (same). As such, a person could mentally analyze an image and determine a fill level, either mentally or using a pen and paper. The mere nominal recitation that the various steps are being executed by model(s) in a device (e.g. processing unit) does not take the limitations out of the mental process(s) grouping. Thus, the claims recite a mental process.
STEP 2A (PRONG 2): Does the claim recite additional elements that integrate the judicial exception into a practical application? NO, the claims do not recite additional elements that integrate the judicial exception into a practical application.
With regard to STEP 2A (prong 2), whether the claim recites additional elements that integrate the judicial exception into a practical application, the guidelines provide the following exemplary considerations that are indicative that an additional element (or combination of elements) may have integrated the judicial exception into a practical application:
an additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
an additional element that applies or uses a judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition;
an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
an additional element effects a transformation or reduction of a particular article to a different state or thing; and
an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
While the guidelines further state that the exemplary considerations are not an exhaustive list and that there may be other examples of integrating the exception into a practical application, the guidelines also list examples in which a judicial exception has not been integrated into a practical application:
an additional element merely recites the words “apply it” (or an equivalent) with the judicial exception, or merely includes instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea;
an additional element adds insignificant extra-solution activity to the judicial exception; and
an additional element does no more than generally link the use of a judicial exception to a particular technological environment or field of use.
3. Claim(s) 2-24 does/do not recite any of the exemplary considerations that are indicative of an abstract idea having been integrated into a practical application. Claim(s) 2-24 and recite(s) the further limitations of:
The features of claims 2-24 do not add additional element reflecting an improvement in the functioning of the computer system, or an improvement to other technology or technical field; do not add additional element(s) that applies or uses a judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition; do not add additional element(s) implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim; do not add additional element(s) that effects a transformation or reduction of a particular article to a different state or thing; or do not add additional element(s) that applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
The limitations of claims 2-24 are recited at a high level of generality (i.e. as a general action or change being taken based on the results of the acquiring step) and amounts to mere post solution actions, which is a form of insignificant extra-solution activity. Further, the claims are claimed generically and are operating in their ordinary capacity such that they do not use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
STEP 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? NO, the claims do not recite additional elements that amount to significantly more than the judicial exception.
With regard to STEP 2B, whether the claims recite additional elements that provide significantly more than the recited judicial exception, the guidelines specify that the pre-guideline procedure is still in effect. Specifically, that examiners should continue to consider whether an additional element or combination of elements:
adds a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; or
simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.
Claim(s) 1-25 does/do recite any additional elements that are well-understood, routine or conventional. The use of a well known techniques to manipulate the captured image are routine, well-understood and conventional process that is performed by computers.
Thus, since Claim(s) 1-25 is/are: (a) directed toward an abstract idea, (b) do not recite additional elements that integrate the judicial exception into a practical application, and (c) do not recite additional elements that amount to significantly more than the judicial exception, it is clear that Claim(s) 1-25 is/are not eligible subject matter under 35 U.S.C 101. The features of claims 2-24 recite insignificant pre-solution extra activity of generating data and processing data; Accordingly, the additional element(s) does/do not integrate the abstract idea into a practical application because the limitation(s) does/do not impose any meaningful limits on practicing the abstract idea.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
4. Claim(s) 1-3,10-12,15-21 and 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Glaser et al. (2017/0323376), hereafter referred as Glaser.
With regard to claim 1, Glaser teaches a system for monitoring critical enclosure defining an interior space (reads on p[0035, which described that the system and method of ‘376 can be implemented in a container or enclosure), at least one camera (100) installed so as to record image frames of the interior space (reads p[0044 AND 0169] and fig. 2, which depicts how camera can captured regions or frames within an enclosed area), and a controller (210) is configured to: receive the image frames recorded by the at least one camera (reads p[0044, 0142 or 0169] and fig. 2, which depicts how camera can captured regions or frames within an enclosed area is received for processing) , analyze the image frames to detect an event captured by one or more of the image frames using a first model (see p[0035-0037,0042,0045,0102 or 0142], clearly a model or machine intelligence can be used to analyze the captured frames or images and detect interactive events), perform a classification of an intervention captured by one or more of the image frames using a second model, the second model (or multi-stage modeling) being trained with image frames of interventions assigned to at least two different classes (reads on figs. 2,9,13 and claim 1, an image captured can be classified and different modeling can be implemented as a multi-stage modeling as depicted in fig. 13, and p[0211] suggest inspecting can be automatic inspection triggered by various rules, conditions or other algorithms) , and provide a notification indicating one of the at least two different classes (see fig.9) based on the classification (reads on figs. 9,13 and claim 1, a multi-stage modeling (or second model) as depicted in fig. 13 is used and can be implemented into different classes and can be processed separately and p[0242, describes notification support and customized actions) .
With regard to claim 2, Glaser further teaches a characterized in that wherein the first model is trained with image frames related to events and/or the second model is trained with image frames of interventions, preferably the first and the second model are machine-learned-models (reads on fig. 9, that depicts using different models and p[0142 or 0211], which suggest inspection(s) can be automatically triggered by various rules, conditions or other algorithms).
,
With regard to claim 3, Glaser further teaches a wherein the controller is configured to detect the event by an analysis of at least one pre-defined first region of the respective image frames (see fig. 11, step S230 which detect events) and/or in that the controller is configured to perform a classification of the intervention by an analysis of at least one pre-defined (see p[098]) second region of the respective image frames (reads on fig. 13, that depicts using classification that can be done to different regions with different models).
With regard to claim 10, Glaser further teaches characterized in that wherein the image frames form a video stream wherein the controller is adapted to perform the classification in real-time with respect to the video stream (reads on p[0071 or 0074], the process can be performed to video being processed).
With regard to claims 11-12, Glaser further teaches characterized in that wherein a Random Forest is used as the first model being an event detection model for event detection or classification (inherently reads 9 and p[0085], the ones disclosed are known alternatives).
With regard to claim 15, Glaser further teaches wherein the system is configured to record the interventions and parameters thereof, including at least one of date, time, duration and/or type of intervention time (reads on claim 1, which suggest keeping track of time).
With regard to claim 16, Glaser further teaches wherein the system is configured to document the interventions (read on fig. 1, which allow the system to store or document operations or events).
With regard to claim 17, Glaser further teaches characterized in that wherein the critical pharmaceutical operations comprise the production of medicine or medical (inherently reads on p[0037 and 0044-0046], clearly medical boxes can be sterile container).
With regard to claim 18, Glaser further e wherein the enclosure is equipped with instruments to perform the production of configured to produce medicine or medical nut (inherently reads on p[0044], clearly system and method can be implemented with medicine hut or store for medical items).
With regard to claim 20, Glaser further teaches wherein the interior space is an aseptic interior space (inherently reads on p[0037], clearly system and method can be implemented with medicine hut or store for medical items).
With regard to claim 21, Glaser further teaches wherein the enclosure comprises at least one of a clean room, the location can be a class A, a glove box, an isolator, and/or and a restricted access barrier system (inherently reads on p[0044], a location can be a restricted area) .
With regard to claim 25, the features of claim 25 are covered by the limitations of claim 1 above.
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 (i.e., changing from AIA to pre-AIA ) 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, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
5. Claim(s) 13 and 22 -24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glaser et al. (2017/0323376), hereafter referred as Glaser, as applied to claim 1 above.
With regard to claihm 13, Glaser teaches using different model(s) (see fig. 9) , Glaser fails to teach wherein Shapely Additive exPlanations (use in a machine learning model) are applied to visualize the plurality of HOG features in an image. Examiner takes official notice (MPEP 2144.03) that it is a well known technique to use Shapely Additive exPlanations (use in a machine learning model predictions) are applied to visualize the plurality of HOG features in an image. Therefore, it would have been obvious to one of ordinary skill in the art at the time of invention to provide the system of Glaser with the ability to use a Shapely Additive exPlanations in model(s) of Glaser, in order to allow the system of Glaser to improve accuracy, consistency and fairness provided by Shapely Additive exPlanations.
With regard to claims 22-24, Glaser teaches using an enclosure (see p[0044-0045]). However, Glaser fails to teach further teaches wherein the enclosure comprises one or more glove ports, determine whether or not a respective glove of each of the one or more glove ports is arranged inside or outside of a wall of the enclosure and wherein the pre-defined region of the respective image frames depicts at least one of the one or more glove ports. Examiner takes official notice (MPEP 2144.03) that it is a well known technique to have an enclosure comprises one or more glove ports, determine whether or not a respective glove of each of the one or more glove ports is arranged inside or outside of a wall of the enclosure and wherein the pre-defined region of the respective image frames depicts at least one of the one or more glove ports. Therefore, it would have been obvious to one of ordinary skill in the art at the time of invention to provide the system of Glaser with the ability use glove within an enclosure, in order to allow the system of Glaser to process more highly controlled, sterile and contamination free environment that can be handle with an enclosure with glove ports.
6. Claim(s) 4-9 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glaser et al. (2017/0323376), hereafter referred as Glaser, as applied to claim 1 above, and in further view of Lee (2012/0070036) .
With regard to claims 4-6, Glaser teaches generating representation (reads fig. 9, which depicts generating percentages). Glaser fails to teach computing a difference image between a current frame and a reference frame, performed classification based on the difference image, wherein the reference frame is the last image frame before the event and computing image features using the difference image. However, Lee (in the same field of endeavor “data processing”) teaches computing a difference image between a current frame and a reference frame, performed classification based on the difference image, wherein the reference frame is the last image frame (previous or comparative image) before the event and computing image features using the difference image (reads on abstract and fig. 3). Therefore, it would have been obvious to one of ordinary skill in the art at the time of invention to provide the system of Glaser with the ability to use a difference image as taught by Lee, in order to allow the system of Glaser to detect events and brightness using previous images as taught by Lee (see p[0040-0045)).
With regard to claims 7-9, Glaser further teaches using the second model and classification the captured regions or events (see figs. 9 and 11) . Glaser fails to teach computing a histogram of oriented gradients, HOG, using the difference image, assign each of a plurality of HOG features a value indicating a contribution of the respective HOG feature to the classification of the intervention, and generating a graphical representation of the HOG for presentation on a display device. However, Lee (in the same field of endeavor “data processing”) teaches computing a histogram of oriented gradients, HOG, using the difference image, assign each of a plurality of HOG features a value indicating a contribution of the respective HOG feature to the classification of the intervention, and generating a graphical representation of the HOG for presentation on a display device (reads on p[0013] , generating a HOG (histograms of oriented gradients) descriptor of a region of the difference image that is scanned when it is judged that the scanned region includes a dynamic organ ), which is situated in the same technical context (see abstract)). Therefore, it would have been obvious to one of ordinary skill in at the time of invention to provide the system of Glaser with the ability to use the histogram as taught by Lee, in order to allow the system of Glaser to better display the computed difference between the features and events being processed.
With regard to claim 14, Glaser teaches wherein the at least two different classes (see fig. 9). Glaser fails to indicate that the least two different classes indicate whether or not the detected intervention is critical or non-critical for a process performed within the interior space. However, Lee (in the same field of endeavor “data processing”) teaches different classes indicate whether or not the detected intervention is critical or non-critical for a process performed (reads on p[0043-0047], describe how a value can be critical or not). Therefore, it would have been obvious to one of ordinary skill in at the time of invention to provide the system of Glaser with the ability determine a critical or not critical process histogram as taught by Lee, in order to allow the system of Glaser to improve the monitoring of data.
7. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kim et al. (11,922,728) teaches an associating event with actors using digital imagery and machine learning.
Adhav et al. (11,798,068) teaches monitoring method for a lease management system.
Wallig et al. (11,762,350) teaches methods and systems for detecting occupancy of a space.
8. Any inquiry concerning this communication or earlier communications from the
examiner should be directed to Gabriel I. Garcia whose telephone number is (571)
272-7434. The examiner can normally be reached Monday-Thursday from 7:30 AM-6:00 PM.. The fax
phone number for this group is (571) 273-8600.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's
supervisor, Benny Tieu can be reached on (571) 272-7490. The fax phone
number for the organization where this application or proceeding is assigned is 571-
273-8300.
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/Gabriel I Garcia/
Primary Examiner, Art Unit 2682
March 12, 2026