DETAILED ACTION
This office action is based on the claim(s) submitted and filed on 08/18/2026.
Claims 1, 17, and 18 have been amended.
Claim 11 has been canceled.
Claims 1-10 and 12-18 are currently pending and have been examined.
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 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.
Claim 1-10 and 12-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1-10 and 12-16 are drawn to a device, Claim 17 is drawn to a method, and Claim 18 is drawn to an art of manufacturer, and each of which is within the four statutory categories (i.e., a machine and a process). Claims 1-10 and 12-18 are further directed to an abstract idea on the grounds set out in detail below.
Under Step 2A, Prong 1, the steps of the claim for the invention represents an abstract idea of a series of steps that recite a process for analyzing medical practice data. Collecting a medical practice data to determine statistical result values are steps that could have been performed by a human but for the fact that the claims recite a general-purpose computer processor to implement the abstract idea for which both the instant claims and the abstract idea are defined as Metal Process that can be performed using human mind with the aid of pencil and paper.
Independent Claim 1, and similarly Claims 17 and 18, recites the steps of:
“at least one processor, wherein the processor is configured to
acquire medical practice information including a date and time related to a medical practice and information related to an index value related to the medical practice, wherein the index value comprises an imaging failure rate, and acquire the date and time being included in a reference target period, which is a target period for analysis of an increase or decrease in the imaging failure rate, and a comparison target period, which is a target period for comparison of the increase or decrease in the
derive a difference between a first statistical value of the information related to the
derive an influence degree on the increase or decrease in the index value in the reference target period relative to the comparison target period for each item value of the at least one item, by multiplying the difference by a second statistical value which comprises a total value of a number of times of imaging for each item value in the reference target period,
correct the influence degree based on a distribution of the first statistical value in a specific period longer than the reference target period and the comparison target period
and
perform a display process for displaying the corrected influence degree for each item value included in the at least one item”.
These limitations, as drafted, given the broadest reasonable interpretation cover performance of the limitations by a human mind with aid of pen and paper, reciting an abstract idea for Mental Process and Mathematical Concepts, but for the recitation of generic computer components. For example, the limitations encompass a user the ability to collect a medical practice data, analyze the data deriving a statistical value and compare it to a target value to determine difference, i.e., analyzing health facilities information to determine imaging failure rate and influence degree, and display it, which are steps that that could have been performed by a human to implement the abstract idea “collecting information, analyzing it, and displaying certain results of the collection and analysis" defining steps reciting mental process that could have been performed using a human mind with aid of pen and paper but other than the mere nominal recitation of "processor, memory", to implement the abstract idea for performing the steps of observing, evaluating, judgment and opinion which can be performed using a human mind with the aid of pencil and paper, see MPEP § 2106.04(a)(2)(III). Accordingly, the claim limitations (in BOLD) recite an abstract idea. Any limitations not identified above as part of the Mental Process are deemed "additional elements," and will be discussed in further detail below.
Under Step 2A, Prong 2, this judicial exception is not integrated into a practical application because the remaining elements amount to no more than general purpose computer components programmed to perform the abstract ideas, linking the abstract idea to a particular technological environment. In particular, the claims recite the additional elements such as “processor, memory, non-transitory readable medium” that iteratively takes input data and analyzes said data to determine an output to performing generic computer functions “e.g. display[ing]” for determining a medical practice procedure performance such that it amounts no more than adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea, see MPEP 2106.05(f), generally linking the use of the judicial exception to a particular technological environment or field of use, see MPEP 2106.05(h), and a mere data gathering process that does not add a meaningful limitation to the above abstract idea, see MPEP 2106.04(d). As set forth in the 2019 Eligibility Guidance, 84 Fed. Reg. at 55 "merely include[ing] instructions to implement an abstract idea on a computer" is an example of when an abstract idea has not been integrated into a practical application. Accordingly, looking at the claim as a whole, individually and 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. The claim is directed to an abstract idea.
Under step 2B, the claims do not include additional elements that are sufficient to amount to "significantly more" than the judicial exception because as mentioned above, the additional elements amount to no more than generic computing components, recited at a high level of generality, do not present improvements to another technology or technical field, nor do they affect an improvement to the functioning of the computer itself, that amount to no more than mere instruction to perform the abstract idea such that it amounts no more than adding the words "apply it" (or an equivalent) to apply the exception using generic computer component, see MPEP 2106.05(f). There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and mere instructions to apply an exception using a generic computer component cannot provide an inventive concept, See Alice, 573 U.S. at 223 ("mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention."). The claims are not patent eligible.
Dependent Claims 2-10 and 12-16, include all of the limitations of claim(s) 1 and therefore likewise incorporate the above-described abstract idea. While the depending claims add additional limitations, such as
As for claims 2-4, the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human mind with the aid of pen and paper, “Mental Process” but for, the recitation of the generic computer components which are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more").
As for claims 5-7, 12-14, and 16, the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human mind with the aid of pen and paper, “Mental Process”, but for, the recitation of the generic computer components which are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible. The claims recite additional elements “processor, external device” that implement the identified abstract idea. These hardware components are recited at a high level of generality (i.e., general purpose computers/components implementing generic computer functions; applicant's specification makes no mention of any specific hardware) to perform the steps, e.g., “display...” that amounts to no more than the words "apply it" with a computer because it appears to intend to do so, which would still amount to mere instructions to apply the exception using generic computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Additionally, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The additional elements amount to more than mere instruction to apply the exception using generic computer component and have been re-evaluated under the “significantly more” analysis. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more").
As for claims 8-10 and 15, the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human mind with the aid of pen and paper, “Mental Process” along with Mathematical Concepts, but for, the recitation of the generic computer components which are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible. The claims recite additional elements “processor,” that implement the identified abstract idea. These hardware components are recited at a high level of generality (i.e., general purpose computers/components implementing generic computer functions; applicant's specification makes no mention of any specific hardware) to perform the steps, e.g., “display...” that amounts to no more than the words "apply it" with a computer because it appears to intend to do so, which would still amount to mere instructions to apply the exception using generic computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Additionally, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The additional elements amount to more than mere instruction to apply the exception using generic computer component and have been re-evaluated under the “significantly more” analysis. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more").
Subject Matter Free of Prior Art
Claims 1-10 and 12-18 have been found by the examiner to be free of prior art. A thorough search of prior art was conducted, and the examiner could not find a single reference or combination of references with adequate rationale to combine that would teach the claimed invention.
Specifically, the examiner finds that the language “correct the influence degree based on a distribution of the first statistical value in a specific period longer than the reference target period and the comparison target period” to be free of prior art. In the examiner's search of prior art, the following references were found to be the closest prior art:
- Yamazaki et al. (JP2016071764) discloses evaluation of medical facility and comparison target over a period of time while the evaluation based on medical facility medical information that includes elements to a facility code, hospitalization date, discharge date, hospitalization period, medical treatment date for comparison to a target value and indicating statistical difference and determine factors influencing the difference such as calculating a statics of a management index and the statics of each element index regarding the actual data group of an evaluation object and the actual data group of a comparison object and calculating an influence degree that a change in statistics of the element index provides on a difference amount between the statistics of the evaluation object and the statistics of the comparison object in the management index for each element index.
- US 2022/0028075 “SUGAHARA” discloses analyzes a radiographic image to determine the radiographic image, whose capture is determined to have failed, to be a failure and to decide an imaging failure reason such as position of the image, which is a reason for the determination, and correction information for eliminating the imaging failure reason, and displays the correction information on the display.
- JP 2004318751 “Sogo” discloses a medical practice time measurement system measure a medical practice time of a doctor or the like in a large hospital tending to exceed a prescribed medical examination time.
- JP489721382 discloses measuring medical device usage efficiency.
It have been obvious to one of ordinary skill in the art at the time of filing to have employed the claimed invention because the references taken solely, or in combination, fail to provide the required limitations, and modification of any complementary combination of the references of record would be impermissible. While the prior art does recite features that are similar to the claimed invention for calculating an influence degree that a change in statistics of the health facilities element index, none of the prior art discloses correct the influence degree based on a distribution of the first statistical value in a specific period longer than the reference target period and the comparison target period. For the foregoing reasons, the examiner finds claims 1-10 and 12-18 as free of prior art.
Response to Amendment
Applicant's arguments filed 08/18/2026 have been fully considered by the Examiner and addressed as the following:
In the remarks, Applicant argues in substance that:
Applicant's arguments with respect to the 35 U.S.C. § 101 rejection on page 10-17.
On page 10-11 of the remarks, the Applicant argues “the Office Action characterizes the claimed invention at an unduly high level of abstraction as merely collecting medical information, analyzing the information, and displaying a result. That characterization does not account for the specific processing recited in amended claim 1 ... For each of a plurality of item values of at least one predetermined item, the processor derives a difference between a first statistical value ... The processor then derives an influence degree ... The processor further corrects the influence degree... Accordingly, amended claim I is not directed merely to a human observation, judgment, opinion, or general comparison of two values... The rejection does not explain how this specifically claimed combination, as opposed to a generalized summary of the combination, can practically be performed in the human mind”, Examiner respectfully disagree. Examiner respectfully asserts that the claims are given their broadest reasonable interpretation for the purpose of determining whether they encompass a judicial exception. The claims limitations are directed towards collecting and analyzing health facilities information such that to determine imaging failure rate and influence degree and present it, which are still reciting an abstract idea which recite a mental process when they contain limitations that can practically be performed in the human mind, including for example, observations, evaluations, judgments, and opinions, see MPEP § 2106.04(a)(2)(III) and Electric Power Group v. Alstom., S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016). As described in the above rejection and explained in the prior OA, although the claim(s) recite additional elements, e.g., processor, to implement/apply such steps, these steps can be performed using human mind with the aid of pencil and paper along with mathematical concepts, and even if the steps are claimed as being performed on a computer, the steps of the claims are citing an abstract idea.
On page 12-14 of the remarks, the Applicant argues “amended claim I integrates the claimed calculations into a particular practical application in the field of medical imaging quality analysis ... The claimed processing is specifically applied to medical practice information concerning an imaging failure rate and the number of times of imaging for each item value associated with medical imaging practices... Consequently, the claimed combination improves the accuracy and practical usefulness of medical imaging quality analysis ... This allows the medical institution to direct quality-control measures toward the item values that have the greatest actual effect on the medical imaging workflow” Examiner Respectfully disagree. The claims and the specification provide no evidence, or any description of how the alleged improvement can be achieved. As mentioned above, the claim, under BRI, recite steps that encompass a user to perform the steps mentally and manually applying mathematical steps for analyzing health facilities and imaging failure rate where even if the steps are claimed as being performed on a computer, they are citing steps that are identified as an abstract idea. At best, this imaging failure rate evaluation and outcome may improve the abstract idea for evaluating medical practices using a processor, however, improving upon an abstract idea does not make the abstract idea any less abstract.
Moreover, as per the above response and the claim(s) step(s) emphasized, argued by the Applicant which has/have been analyzed as an additional element recited at a high level of generality performed by a processor recited at as a tool to perform the claimed step(s), that amounts to no more than mere instructions using a generic computer component and no more than adding the words "apply it", see MPEP 2106.05(f). Even when considering the claims additional elements “e.g., processor”, the claims as a whole, individually and in combination, provide no integration of the abstract ideas into a practical application that no meaningful limits on practicing the abstract idea are introduced, see MPEP 2106. The claims as a whole are therefore directed to an abstract idea. In addition, Examiner asserts that the claims as recited do not require a complex computational process to perform the steps.
On page 14-15 of the remarks, the Applicant argues “The claimed invention is therefore materially different from the generalized information processing addressed in Electric Power Group v. Alstom, S.A. In Electric Power Group... Here, amended claim 1 expressly defines the medical imaging data being processed, the relevant target periods ... The claim thus recites a particular manner of producing a medically useful quality indicator rather than merely claiming the desired result of analyzing medical information...” Examiner Respectfully disagree. As described above, the claim(s), under BRI, reciting the performance of data collection, e.g., medical practice data to include imaging data such as failure rate to perform calculation for to generate a statical values and evaluate influencing factors and degree to the failure rate and display it which are steps that are similar to "collecting information, analyzing it, and displaying certain results of the collection and analysis," where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016).
On page 15 of the remarks, the Applicant argues “even assuming, solely for purposes of argument, that amended claim 1 is considered directed to a judicial exception under Step 2A, the claim recites significantly more than the alleged exception... This ordered combination does not merely automate a preexisting manual process or append generic computer activity to a mathematical calculation...” Examiner Respectfully disagree. Applicant's claims do not improve any technological field such as collecting and analyzing medical practice data and provide an assessment to imaging failure rate as this is part of the abstract idea identified. There is no specific process other than what is understood in data receiving and deriving analysis of a medical practice data and determining imaging failure rate using processor recited at a high level of generality such that leveraging generic computing functionality. The claims at issue do not require any nonconventional computer, network, or other components, or even a non-conventional and non-generic arrangement of known, conventional piece, but merely call for performance of the claimed functions on a set of generic computer components.
On page 16 of the remarks, the Applicant argues “The Office Action has not established that this particular ordered combination was well-understood, routine, and conventional in the relevant field. A conclusion that a claim limitation or a combination of limitations is well-understood, routine, and conventional must be supported by a factual determination ... Moreover, the Office has expressly indicated that the limitation concerning correction of the influence degree based on a distribution of the first statistical value in a period longer than the reference target period and the comparison target period is not disclosed by the cited prior art ... the Office cannot rely upon the cited prior art as evidence that the newly claimed combination is well-understood, routine, and conventional when that prior art does not disclose the correction limitation or the claimed combination as a whole” Examiner Respectfully disagree. The steps of the claims, taken individually or as an ordered combination, have already been identified in the rejection above as corresponding to an abstract idea. The additional elements in the claims, “i.e., processor" applied by said "support device" to execute the claimed steps. The claims at issue do not require any nonconventional computer, network, or other components, or even a non-conventional and non-generic arrangement of known, conventional pieces but merely call for performance of the claimed functions on a set of generic computer components. The elements of the instant process, when taken alone, each execute in a manner conventionally expected of these elements. The elements of the instant underlying process, when taken in combination, together do not offer substantially more than the sum of the functions of the elements when each is taken alone.
In addition, according to the USPTO guidelines of April 19, 2018 incorporating the Berkheimer memo (Berkheimer memo, hereinafter),
In a step 2B analysis, an additional element (or combination of elements) is not well-understood, routine or conventional unless the examiner finds, and expressly supports a rejection
in writing with, one or more of the following:
1. A citation to an express statement in the specification or to a statement made by
an applicant during prosecution that demonstrates the well-understood, routine,
conventional nature of the additional element(s).
2. A citation to one or more of the court decisions discussed in MPEP §
2106.05(d)(Il) as noting the well-understood, routine, conventional nature of the additional
element(s).
3. A citation to a publication that demonstrates the well-understood, routine,
conventional nature of the additional element(s).
4. A statement that the examiner is taking official notice of the well-understood,
routine, conventional nature of the additional elements). This option should
be used only when the examiner is certain, based upon his or her personal knowledge,
that the additional elements) represents well-understood, routine, conventional activity engaged
in by those in the relevant art, in that the additional elements are widely prevalent or in common
use in the relevant field, comparable to the types of activity or elements that are so well-known
that they do not need to be described in detail in a patent application to satisfy 35 U.S. C. §
112(a).
The fact that the additional elements, such as described above, can be suitably programmed to perform the claimed method without requiring any nonconventional computer, network, or other computing components, or even a "non-conventional and non-generic arrangement of known, conventional pieces" but instead merely call for performance of the claimed functions on a set of generic computer components, satisfies the Berkheimer memo requirement that the additional elements are conventional elements (as outlined in criterion 1 of the Berkheimer memo). Furthermore, Examiner has pointed to the computing functionality leveraged as well-understood, routine and conventional computing functionality, both individually and in combination, See MPEP 2106.05(d). The elements of the instant process, when taken alone, each execute in a manner conventionally expected of these elements. The elements of the instant process, when taken in combination, together do not offer substantially more than the sum of the functions of the elements when each is taken alone. Hence, these additional elements do not add anything significantly more than an abstract idea.
Moreover, Examiner asserts that all of the requirements for patentability as provided in 35 U.S.C. 101, 102, 103, and 112 must be met before a claim is allowed, see MPEP 706(I).
On page 17 of the remarks, the Applicant argues “The amended limitations do not merely add another abstract calculation to the claim ... Thus, even if the derivation and correction operations are regarded as mathematical concepts, the remaining limitations and their ordered combination impose meaningful limits on those concepts and provide an inventive application in medical imaging quality analysis. The claim as a whole therefore amounts to significantly more than the alleged judicial exception under Step 2B” Examiner Respectfully disagree. As described above, the elements of the instant underlying process, when taken in combination, together do not offer substantially more than the sum of the functions of the elements when each is taken alone. Limitations that the courts have found to qualify as "significantly more" when recited in a claim with a judicial exception include adding a specific limitation other than what is well-understood, routine, conventional activity in the field, or adding unconventional steps that confine the claim to a particular useful application, e.g., a non-conventional and non-generic arrangement of various computer components for filtering Internet content, as discussed in BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1350-51, 119 USPQ2d 1236, 1243 (Fed. Cir. 2016). Hence, the instant claim(s) steps and additional elements do not add anything significantly more than an abstract idea.
Therefore, the Examiner has addressed the Applicant argument(s) and found this argument is not found to be persuasive. Hence, Examiner remains the 101 rejections of claims which have been updated to address Applicant's amendments.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALAAELDIN ELSHAER whose telephone number is (571)272-8284. The examiner can normally be reached M-Th 8:30-5:30.
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/ALAAELDIN M. ELSHAER/Primary Examiner, Art Unit 3687
