DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restriction
Applicants’ election without traverse of Species A (claim 43) and Species B (claim 46), filed 01/20/2026 is acknowledged. In addition, as indicated in the interview summary filed 01/12/2026, claims 52 and 65 in the species election should be have claims 51 and 63, respectively. Accordingly, claims 44, 45, and 48-64 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Status of Claims
Claims 27, 43, 46, 47, 65, and 66 are under examination.
Claims 1-26 are cancelled. Claims 44, 45, and 48-64 are withdrawn.
Priority
Applicant’s claim for the benefit of foreign priority under 35 U.S.C. 119(a)-(d) to Japanese Patent Application No. 2021-030891, filed on February 26, 2021, is acknowledged. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Drawings
The drawings filed 02/25/2022 are acceptable.
Information Disclosure Statement(s)
The five (5) information disclosure statement (IDS) document(s) submitted are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS document(s) has/have been fully considered by the examiner.
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 27, 43, 46, 47, 65, and 66 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.
The United States Patent and Trademark Office published revised guidance on the application of 35 U.S.C. § 101. USPTO’s 2019 Revised Patent Subject Matter Eligibility Guidance (“Guidance”). Under the Guidance, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes) (Guidance Step 2A, Prong 1); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)) (Guidance Step 2A, Prong 2).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that are not “well-understood, routine and conventional in the field” (see MPEP § 2106.05(d)); or 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50-57 (January 7, 2019).
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.(Guidance Step 2B). See Guidance, 84 Fed. Reg. at 54-56.
Guidance Step 1:
The instant invention (claim 27 being representative) is directed to a system that performs a series of processes. Thus, the claims are directed to one of the statutory categories of invention. MPEP 2106.03.
A. Guidance Step 2A, Prong 1
The Revised Guidance instructs us first to determine whether any judicial exception to patent eligibility is recited in the claim. The Revised Guidance identifies three judicially-excepted groupings identified by the courts as abstract ideas: (1) mathematical concepts, (2) certain methods of organizing human behavior such as fundamental economic practices, and (3) mental processes. In this case, the claimed steps that are part of the abstract idea are as follows:
“a first computer configured to control the analyzer and transmit, via a network, an analysis result to a second computer configured to manage the analysis result comprising a first controller and a first storage storing first setting information about a control program for the analyzer, second setting information about communication with a second computer configured to manage analysis results by the analyzer, and analysis results by the analyzer, the first computer being configured to control the analyzer in accordance with the control program under the first setting information and configured to transmit, via a network and on the basis of the second setting information, the analysis results in the first storage to the second computer.”
Mental Processes
Under the broadest reasonable interpretation, the above italicized steps amount to managing/analyzing data using a ‘control program’. Notably, the claims do not impose any boundaries on how the italicized functions are actually being achieved. Accordingly, the above steps clearly fall within the mental process groupings of abstract ideas because they cover concepts performed in the human mind, including observation, evaluation, judgment, and opinion. See MPEP 2106.04(a)(2), subsection III [Step 2A, Prong 1: YES].
B. Guidance Step 2A, Prong 2
This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception or whether the claim is “directed to” the judicial exception. This evaluation is performed by (1) identifying whether there are any additional steps/elements recited in the claim beyond the judicial exception, and (2) evaluating those additional steps/elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. See MPEP 2106.04(d). The additional steps/elements recited in the claim beyond the judicial exception are as follows:
an analyzer configured to analyze a specimen, the analyzer comprising a sample preparator configured to prepare a measurement sample from a specimen and a reagent;
detector configured to detect an analyte in the measurement sample; first computer; second computer; storage
In this case, the above analyzer and detector are recited at a high of generality and result in nothing more than collecting data for use by the abstract idea. Accordingly, the above steps/elements amount to insignificant extra-solution activity and are not indicative of an integration into a practical application. See MPEP 2106.05(g). Regarding the first and second computers and storage, these features are generically recited and merely used as tools to obtain information or perform the abstract idea. Moreover, applicant is reminded that “generic computer components such as a computer and database do not satisfy the inventive concept requirement.” See MPEP 2106.05(f) and 2106.05(h). Even when viewed in combination, these additional steps/elements do not integrate the recited judicial exception into a practical application. [Step 2A, Prong 2: NO].
For a list of considerations when evaluating whether additional elements integrate a judicial exception into a practical application see MPEP 2106.04(d)(1) lists the following example considerations for evaluating whether a judicial exception is integrated into a practical application:
An improvement in the functioning of a computer or an improvement to other technology or another technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
Applying or using 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, as discussed in MPEP § 2106.05(e).
C. Guidance Step 2B:
This part of the eligibility analysis evaluates whether the claim as a whole amount to significantly more than the recited exception i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. See MPEP 2106.05. In addition, Koeda et al. (US2014/0297226; Pub. Date: 10/02/2014) teaches that the claimed analyzer, detector, and computers were all routine and conventional in the art. Therefore, even upon reconsideration, there is nothing unconventional with regards to the above non-abstract steps. See MPEP 2106.05(d)(Part II). Thus, the independent claim(s) as a whole do not amount to significantly more than the exception itself. Therefore, the claim(s) is/are not patent eligible. [Step 2B: NO].
D. Dependent Claims
Dependent claims 43, 46, 47, 65, and 66 have also been considered under the two-part analysis but do not include additional steps/elements appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception(s) for the following reasons. Regarding claim(s) 43, 46, 47, 65, and 66, these claims further limit the specificity of the abstract idea or the nature of the data being used by the abstract idea. Accordingly, these claims are also directed to an abstract idea for the reasons set forth above (Step 2A, prong 1 analysis). Therefore, the instantly rejected claims are not drawn to eligible subject matter as they are directed to an abstract idea without significantly more.
Claim rejections - 35 USC § 112, 2nd Paragraph
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 27, 43, 46, 47, 65, and 66 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 that depend directly or indirectly from claim(s) 27 are also rejected due to said dependency.
Claim 27 recites “an analyzer configured to analyze a specimen, the analyzer comprising a sample preparator configured to prepare a measurement sample from a specimen and a reagent.” It is unclear as to the metes and bounds of the claimed “analyzer” such that one of skill in the art would recognize what structural limitation is intended based on common knowledge in the art. In this case, the specification teaches a “measurement unit” that includes a “sample preparation part” that mixes the specimen and predetermined reagents with each other [0085-0088], and thus appears to perform the function of the claimed “analyzer”. However, this is not commensurate in scope with what is being claimed and thus amounts to a conflicting description. Clarification is requested by amending the claims to clarify what specific structure or equivalent is intended. As a result, it is also unclear as to the metes and bounds of the “sample preparator” such that the artisan would recognize what structural limitation is intended. A review of the specification does not provide any limiting definition for this term that would serve to clarify the scope. As discussed above, the specification does teach measurement unit that includes a “sample preparation part” [0085-0088]. However, this is not commensurate in scope with what is being claimed. Clarification is requested via amendment.
Claim 27 recites “a first computer configured to control the analyzer and transmit, via a network, an analysis result to a second computer configured to manage the analysis result comprising a first controller and a first storage storing first setting information about a control program for the analyzer, second setting information about communication with a second computer configured to manage analysis results by the analyzer, and analysis results by the analyzer, the first computer being configured to control the analyzer in accordance with the control program under the first setting information and configured to transmit, via a network and on the basis of the second setting information, the analysis results in the first storage to the second computer.” The above limitations are problematic for the following reasons.
With regards to “…an analysis result to a second computer configured to manage the analysis result comprising a first controller and a first storage storing first setting information about a control program for the analyzer”. It is unclear what structural and functional limitations of the claimed analysis system are intended by this phrase, i.e. is the second computer a structural element of the claimed analysis system or not. If so, it is not readily apparent (as the claimed system does not explicitly “comprise” a second computer). In addition, it is unclear in what way the “analysis result” comprises a “first controller and a first storage” (as a result cannot comprise physical elements). Clarification is requested via amendment.
Second, with regards to the phrases “second setting information about communication with a second computer”, it is unclear what limiting effect is intended by the phrase “about communication with a second computer” such that the artisan would recognize what type of “information” is minimally required. As a result, it is unclear as to the metes and bounds of the “second setting information”. The specification does not provide any limiting definition that would serve to clarify the scope. Clarification is requested via amendment.
Third, with regards to “first setting information about a control program for the analyzer”, it is unclear what limiting effect is intended by the phrase “about a control program for the analyzer” such that the artisan would recognize what type of “information” is minimally required. As a result, it is unclear as to the metes and bounds of the “first setting information”. The specification does not provide any limiting definition that would serve to clarify the scope. In addition, it is also unclear whether or not the “control program” is actually being stored in and executed by the first computer. Clarification is requested via amendment. The Examiner also suggests that applicant replace the term “storage” with a non-transitory computer-readable medium (encoded with a program that performs instructions).
Fourth, with regards to the phrase “with a second computer configured to manage analysis results by the analyzer”, this phrase is confusing because the “analyzer” as claimed does not appear to include any structural elements that are capable of performing “analysis” (e.g. processor) but is merely configured to prepare a measurement sample. In addition, it is also unclear as to the metes and bounds of the claimed “analysis results”. Neither the claims nor the specification provides any limiting definition that would serve to clarify the scope or nature of the analysis. Therefore, it is unclear what structural or functional limitations of the claimed “analysis system” is/are intended by the above phrase. Clarification is requested via amendment.
Fifth, with regards to the phrase “the first computer being configured to control the analyzer in accordance with the control program under the first setting information”, such generic functional claim language amounts to descriptions of problems to be solved and covers all means or methods of performing the claimed functions. A review of the specification does not describe, to any appreciable extent, any algorithms, equations, or prose equivalent that correspond to the claimed “control program”. As a result, it is unclear what computational techniques are included or excluded such that one of ordinary skill in the art would know what computational limitations are intended, i.e. in what way is the analyzer being controlled “in accordance” with the control program. Clarification is requested via amendment.
Claim 27 recites “and the third computer is configured to, instead of the first computer, control the analyzer on the basis of the stored setting information about the control program and transmits an analysis result to the second computer on the basis of the stored setting information about the communication in accordance with the control program under the stored first setting information...”. The above limitations are problematic for the following reasons.
First, with regards to the phrase “instead of the first computer”, this is confusing because the first computer already comprises a controller for controlling the analyzer. According, this phrase renders the claim indefinite because it suggests an alternate functional limitation that conflicts with a previously claimed function (without clarifying what change in conditions brings about this alternate function). Applicant is reminded that language that suggests or makes optional but does not require steps to be performed or does not limit a claim to a particular structure does not limit the scope of a claim or claim limitation. See also MPEP § 2111.04. Clarification is requested via amendment.
Second, with regards to the phrase “on the basis of the stored setting information about the communication in accordance with the control program under the stored first setting information”, it is unclear what limiting effect is intended, i.e. in what way is the third computer configured “on the basis” of the stored setting information “in accordance” with the control program “under the stored first setting information.” A review of the specification does not provide any limiting definitions or clarifying examples. Therefore, the claim is indefinite for failing to point out the requisite computational techniques that are included or excluded by the claim language, such that the artisan would know how to avoid infringement. Clarification is requested via amendment.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 27, 43, 46, 47, 65, and 66 are rejected under 35 U.S.C. 103 as being unpatentable over Koeda et al. (US2014/0297226; Pub. Date: 10/02/2014).
Regarding claim(s) 27, Koeda teaches a sample analysis method and system. In particular, the system comprises a sample analyzer configured to obtain information from the sample (e.g. blood analyzer for determining blood count) comprising a measurement section that includes an aspirating pipette, a sample preparation portion, and a detecting portion [Abstract, 0028-0030, 0032, 0033, Figures 1-2], which broadly reads on an analyzer and detector as claimed.
Koeda teaches the analyzer includes an information processing unit (first computer) configured to perform control of sample measurement apparatus and analysis of measurement data, and comprising a processing section, storage section, display device, and has a function similar to that of a personal computer [Abstract, 0030, 0057, ref. claim 1, Figure 1]. Koeda teaches that the data processed by the first computer can include measurement data, analysis settings, and display settings [0056], which broadly reads on first and second setting data. Koeda teaches a second computer that executes a control program, wherein the control program is configured to control the sample measuring device, initiate sample measurement, receive data, and transmit measurement data to an external server [0007, ref. claims 1-4, and 15]. The computers are connected via a network [0008, 0028, 0034, ref. claim 15]. Therefore, given the indefiniteness of the claim, Koeda at a minimum suggests the claimed first computer, second computer, control program, network, and storage as claimed.
Koeda does not specifically teach a third computer comprising a second controller and storage, as claimed. However, Koeda makes obvious this feature by teaching a replacement or alternate computer that can replace said first computer [0038-0041, 0042] as well as an external server configured to execute an analysis program to analyze measurement data; generate analysis results, and save the generated results to a storage component (i.e. second storage) [0008, 0080, 0106], and since one of ordinary skill in the art would recognize the external server is just a computer that performs all of the functionality of the first and second computers set forth above.
Regarding claim(s) 43, Koeda teaches an external server (i.e. third computer) configured to execute an analysis program to analyze measurement data; generate analysis results, and save the generated results to a storage component (i.e. second storage) [0008, 0080, 0106] and since one of ordinary skill in the art would recognize the external server is just a computer that performs all of the functionality of the first and second computers set forth above.
Regarding claim(s) 46, Koeda teaches that any of the aforementioned computers can be configured to download the control program used to control the measurement device (i.e. analyzer) [Abstract, 0007, 0066, ref. claim 1, Figures 1-2]. Regarding claim(s) 47, Koeda teaches that the data processed by the above computers can include various types of setting and schedule information [0056, 0077]. Regarding claim(s) 65, Koeda does not specifically teach an identical version of the control program in a second storage. However, Koeda reasonably suggests this feature since the control program run by the external server as set forth above performs the same function (namely controlling the measurement device). Regarding claim(s) 66, Koeda teaches the various computers are configured to transmit data, as set forth above, and update the data being stored allowed for synchronization between computers [0120-0125 and Figures 1-2], which at a minimum suggests the claimed functions.
Cited Prior Art
In light of the confusing aspects of the claimed invention, as discussed in the rejections under 35 USC 112(b), above, the Examiner was not able to properly interpret the claims for purposes of applying prior art. However, the following prior art made of record and not relied upon is considered pertinent to applicant' s disclosure.
Satomura et al. (US 9222950), which teaches an analysis apparatus using a reagent container having a memory to store reagent information concerning the reagent in the reagent container and a remote computer.
Yamada et al. (US 20100080440), which teaches a blood cell image display apparatus comprising: a classifier for classifying blood cell images, which are obtained by imaging a blood smear prepared from a blood specimen, in accordance with types of blood cells in the blood cell images; an information receiver for receiving information relating to the blood specimen; a display section; and a display controller for determining a type of blood cell as a display object on the basis of the information relating to the blood specimen, and displaying a blood cell image classified as the determined type on the display section.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PABLO S WHALEY whose telephone number is (571)272-4425. The examiner can normally be reached between 1pm-9pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Anita Coope can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PABLO S WHALEY/Primary Examiner, Art Unit 3619