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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims.
i. “the analytical sample vessel” found in at least independent claims 1, 17 and 20, and
ii. “pipette module/means capable of dispensing” in claim 2 and 21 (note: the examiner does not find the box of the “preparation device” can be relied upon for showing the dispensing means),
must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to under 37 CFR 1.83(a) because they fail to show
i. the analytical sample vessel delivered from the transport module 1300 to the analysis device 12 in Fig. 3 as described in the specification (note the transport path as indicated by an arrow in Fig. 3 is only shown going one way from the analysis device to the transport module, see para [0066]); and
ii. “the driving software of each of the preparation device 2100 and analysis device 2200”, see para [0132] et seq.
Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d).
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “1410” has been used to designate both “sealing portion” and “sealing unit” in para [0074].
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "1112" and "1300" have both been used to designate “transport module”.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Specification
The disclosure is objected to because of the following informalities: Brief Description of the Drawings section does not include a brief description of Fig. 10. The specification also recites at para [0086] “the aforementioned door”, which is not previously disclosed in the specification or shown in the figures. The examiner recommends applicant amend this to recite --a door (not shown in Figures)--. Appropriate correction is required.
The disclosure is objected to because of the following informalities: para [0108] recites “after the transport module 1112 moves toward the transport unit 1310, the driving software 1510 of the preparation device 1100 repeatedly identifies whether the file is stored in the system control unit module using the API provided by the API unit 1512, that is, the file reading API”. It is not clear how the transport unit 1310 which is portion of the transport module” can move toward itself. Clarification is requested.
The specification at para [0124]-[0129] with respect to Figs. 6 and 7 discloses that the transport module moves the sample vessel to the sealing 1400 using a gripper. However, the gripper appears to be part of the preparation device, not the transport device (see para [0049] et seq.) Clarification is requested.
The second embodiment as described in para [0134] discloses that “the system control module delivers or process an analytical vessel between the preparation device 2100 and analysis device 2200”. This overlaps the recited purpose of the transport module. Clarification is requested.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 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) 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):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) 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) 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) except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. For example, “ink delivery means”, “module configured to deliver ink” and “means for ink delivery” could all be interpreted as claim elements that invoke 35 U.S.C. 112(f) (see MPEP 2181 I B).
Such claim limitation(s) is/are:
i. “preparation device for preparing an analysis target sample in an analytical sample vessel” in at least independent claims 1, 17 and 20, has been interpreted by the examiner as corresponding to pipette module which includes a pipette tip, arm that moves the pipette tip, and a gripper as disclosed in at least para [0049], [0105], of applicant’s specification or structural equivalents thereof;
ii. “transport module for transporting the analytical system vessel” in at least independent claims 1 and 17, has been interpreted by the examiner as corresponding to transport unit 1310, a position detector 1320, and a contact detector 1330, as disclosed in at least para [0067] of applicant’s specification or structural equivalents thereof;
iii. “analysis device for performing an analysis operation” in at least claims 15, 16 and independent claim 20, has been interpreted by the examiner as corresponding to a thermocycler and optical module, as disclosed in at least para [0064] of applicant’s specification or structural equivalents thereof.
iv. “sealing device for sealing…a vessel” in claims 13 and 14, has been interpreted by the examiner as corresponding to “sealing unit 1410”. However, the corresponding structure of the sealing unit has not been disclosed. For example applicant’s specification at para [0074], discloses the sealing unit is capable of adhering a transparent film to the top of the vessel but does not describe the structure that performs the capable of performing the claimed function.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) applicant may:
(1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) (e.g., by reciting sufficient structure to perform the claimed function); or
(2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f). Note: the examiner considers a “sufficient showing” as defined under §112(f) as a clear, definite disclosure in the specification of the structure, material, or act that performs the claimed function, so that the broadest reasonable interpretation (BRI) of the claim limitation is confined to that disclosed structure and its equivalents.
In the patentability analysis of the instant system claims, aspects or limitations examiner interprets as functional are generally italicized whereas aspects interpreted as structural components are normally bolded. The bold font and italics are shown when the structure and function are initially introduced though not necessarily repeated, particularly in dependent claims. The examiner applies this formatting for both the examiner and applicant’s convenience. However, absent the referenced typestyles, the patentability analysis will still be clear regarding which limitations the examiner interprets as structural versus functional.
Claims 1-16 and 20-26 are apparatus claims requiring only the recited structural components, although structured with physical features that can perform the stated functions/process or the intended uses. Functional limitations state either an intended use or operation, a manner of operating a device, apparatus or system, or what the apparatus/system does. Of course, in the patentability analysis of the apparatus claims, the examiner has not ignored the functional/process/intending use features. These functional/process/use recitations in the apparatus claims have been considered and received the appropriate amount of patentable weight consistent with current US patent practice. That is, if a prior art structure is capable of performing the intended use, or if such apparatus can operate in the manner described, then it meets the claim limitation (MPEP §§ 2114, 2173.05(g)).
The below patentability analysis provides one or more interpretations and claim mappings of the claimed structures and/or limitations although other interpretations may be possible. In the patentability analysis, the Office applies the broadest reasonable interpretation (BRI) consistent with the specification. However, specific limitations from the specification are not read into the claims. See MPEP §§2111, 2173.01 I.
Note: the claimed “system control module” has been interpreted by the examiner as a computer and equivalents thereof. That is, the “system control module” has been interpreted in the context of the underlying specification and field of the art (see MPEP 2111.01). Looking to applicant’s specification (US publication 2024/0230699), the “system control module” has been defined as a computer or structural equivalents thereof, see para [0167] et seq. rather than a mechanical type of controller like a switch, valve, or a discrete electronic device (e.g., solenoid, transistor,…).
In the analyzer art, the specific language associated with the controller in the claim will determine how much patentable weight is given to the controller, as supported by the specification. For example, a controller using linking phrases “programmable to”, “configurable to”, “adaptable to” are broad recitations that do not require the ability to actually do the function recited as-is because the functional language merely recite the ability of the controller to be modified to perform the function. A controller using linking phrases “that/for/to”, “adapted to/for”, “configured to/for”, “programmed to/for” and “capable of” carrying out the process parameters suggests that the controller is intentionally designed to execute particular tasks without modification. In this case, applicant’s claims do not use linking phrases with respect to the system control module. In the interest of compact prosecution, the examiner has interpreted the system control module as intentionally designed to execute particular steps without modification (e.g., store a file in which status information is recorded and use API to read the file in order to determine the recorded status information). However, the examiner requests that applicant amend the claims such that the system control module is configured to control the various devices and clearly delineate the control steps for clarity. That being said, the claims are generally narrative and indefinite, failing to conform with current U.S. practice for the reasons delineated below.
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.
Claims 1-17 and 20-26 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1, 17 and 20 are directed to assembled an analysis systems and method of operating the same. However, the claims do include a positively recited analysis device for performing an analysis operation on a target nucleic acid molecule or a step of performing analysis. Thus, these claims are incapable of performing the recited function of analysis. This is confusing and indefinite since it is not clear how a preparation device, transport module and a system control module are capable of performing the recited purpose (i.e., analysis) without an analysis module. The examiner recommends applicant include the limitations of at least claim 15 in order to overcome this rejection.
Claim 1 recites a system control module including a driving software of the preparation device and configured to store/record status information of the transport module in a file (presumably in some memory in communication with the system control module). The driving software also includes a file reading application programming interface (API) configured to read the stored/recorded status information in the file (previously?) stored/record by drive software. It is not clear from the claims what is inventive about using API software to record/store/read a file the status of the transport module. Furthermore, it is not clear how the “status information of the transport module” is determined. It appears that would require some unclaimed detector/sensor in the transport module that indicates the status of the transport module to the system control module. Lastly, the claimed system control module does nothing with the status information. This is confusing and indefinite. Similar deficiencies apply to the method 17 and system claims 20-26.
Claim 3 recites “the driving software includes no API for directly identifying a status of the transport module”. This is confusing and indefinite since claim 1 from which claim 3 depends recites “wherein the driving software includes a file reading API”. Thus, these claims contradict each other. Also, it is not clear from the claim or specification what “directly” identifying a status means. Furthermore, it is not clear if “a status of the transport module” is referring to same “status of a transport module” as disclosed in claim 1.
Claim 4 recites wherein the status information is identified from at least one of the presence or absence of the file, a file name of the file, and content of the file. The presence or absence of the file is unclear. The presence of the file appears to be required in claim 1. Similar deficiencies were found in claims 5-12 and 20-26.
Claims 13 and 14 recite a “sealing device” that for the reasons delineated above, invoke(s) 35 U.S.C. 112(f). However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Specifically, the disclosure is devoid of any structure that implicitly or inherently performs the function in the claim. Therefore, the claims are indefinite under 35 U.S.C. 112(b).
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f);
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181. However, “[a] bare statement that known techniques or methods can be used does not disclose structure” in the context of limitation that invokes an interpretation under 35 USC 112(f), see MPEP 2181 II A.
In addition, MPEP 2106.04(a) details that the claims must reflect applicant’s disclosed improvement in the specification. Specifically MPEP 2106.05(a), 4th paragraph states the claim must include the components or steps of the invention that provide the improvement described in the specification. Looking to applicant’s specification, beginning at para [0009] states that according to an embodiment of the present disclosure, the present disclosure provides an assembled analysis system that may be completed by adding an additional module device and the liquid handling device described above and assembling them. It is not clear from the claims what applicant considers the additional device added to the existing system.
Next, applicant’s specification at para [0010] states an embodiment of the present disclosure enables the aforementioned liquid handling device to determine a status of the aforementioned additional module using only a function already provided in the liquid handling device, that is, without adding new functions. It is not clear from the claims or the specification how the addition of another module to the preparation device and the transport module/analysis modules,(which inherently include additional functions therein) are able to interface with the already provided devices/modules in the system without adding additional functions.
Applicant’s specification at para [0011] discloses another embodiment that allows a file generated by the liquid handling device to be delivered to the RT-PCR device without adding a new function to functions originally supported by the aforementioned liquid handling device and RT-PCR device. It is not clear how generating a file using a software in a control module provide any improvement stated in the specification.
Claims 11 and 25 recite wherein the preparation device detects whether the file is stored in the system control module using a polling method or an interrupt method. It is not clear from the claims or specification what method steps are included in a polling or interrupt methods. However, the specification does disclose these are known as steps performed manually by people at the time when the devices were developed and approved (see para [0081] et seq.). It is not clear how these manual steps performed by people would integrate with the system control module. The scope of the claims cannot be determined.
Claims 12 and 26 recite the preparation device is an approved device as an independently operated device. It is not clear from what is an “approved device” and how it relates to independently operated.
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 1-17 and 20-26, as best understood, are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the system control module includes a driving software and configured to store a file (on an implied storage medium), wherein the storage medium is not disclosed as a computer readable media that includes “non-transitory” data. The USPTO recognizes that applicants may have claims directed to computer readable media that cover signals per se, which the USPTO must reject under 35 U.S.C. § 101 as covering both non-statutory subject matter and statutory subject matter. In an effort to assist the patent community in overcoming a rejection or potential rejection under 35 U.S.C. § 101 in this situation, the USPTO suggests the following approach. A claim drawn to such a computer readable medium that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. § 101 by adding the limitation "a system control module including a driving software of the preparation device and configured to store a file on a non-transitory computer readable medium" to the claims 1, 17 and 20. Such an amendment would typically not raise the issue of new matter, even when the specification is silent because the broadest reasonable interpretation relies on the ordinary and customary meaning that includes signals per se. The limited situations in which such an amendment could raise issues of new matter occur, for example, when the specification does not support a non-transitory embodiment because a signal per se is the only viable embodiment such that the amended claim is impermissibly broadened beyond the supporting disclosure. See, e.g., Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473 (Fed. Cir. 1998).
Claims 1-17 and 20-26, as best understood, are also further rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The instant rejection reflects the Guidance published in the Federal Register notice titled 2019 Revised Patent Subject Matter Eligibility Guidelines (Vol. 84, No. 4, Monday January 7, 2019 at 50) and the October 2019 Updated Subject Matter Eligibility Guidance (hereinafter both referred to as the “Guidance”).
Framework with which to Evaluate Subject Matter Eligibility:
(1) Are the claims directed to a process, machine, manufacture or composition of matter;
(2A) Are the claims directed to a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea (Prong One); If the claims are directed to a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
(2B) If the claims are directed to a judicial exception and do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
With regard to (1), the instant claims are directed to a machine (“an assembled analysis system” in claims 1 and 20) and (“method of obtaining status information of the transport module”) in claim 17, and therefore the answer is "yes".
With regard to (2A), Prong One, under the broadest reasonable interpretation (BRI), the instant claims recite claim steps directed to the judicial exception that is an abstract idea of the type that is in the grouping of “mental process” (See MPEP 2106.04(a)(2) subsections (I) and (III)) because said operations could be performed in the mind, but for the recitation of a “preparation device”, “transport module”, “a system control module” including a driving software of the preparation device, wherein the driving software is configured to store/record status information of the transport module in a file (memory?), which the software then uses an API to store/read/identify the status information. Mental operations in the instant claims are recited as: “obtaining information”, “storing this information” and “identifying this information”, as gleaned from the method 17. In summary, the claim(s) recite(s) an abstract idea, “obtaining information”, “storing the information”, and “reading/identifying the information”.
Said recited judicial exception steps are directed to storing information and reading the information, but for the recitation of the system control module (computer containing software) these can be performed in the mind. A claim, under its BRI, which covers performance of the limitation in the mind, but for the recitation of generic computer elements, falls within the “mental processes” grouping of abstract ideas (see MPEP 2106.04(a)(2)(III)(C)). MPEP in 2106.04(a)(2)III says: “The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation.”, and also says “[n]or do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer.” Applicants rely on a computer (system control module) as a tool to perform the abstract idea MPEP 21604(a)(2) III C. In this case, the claims are directed towards gathering data and reading the data, that could easily be can be done as a mental process with pencil and paper (or a computer).
Because the claims are directed to abstract ideas, they must further be analyzed under Prong Two to determine if said judicial exceptions are integrated into a practical application as determined by further assessment of the “additional steps” recited in the claims. With respect to Prong Two, the additional elements and the rationale pertaining to why the additional elements are not integrated, are as follows:
(a) The claims recite mental steps (judicial exception) which are not integrated into a practical application because the claims amount to mental processes/data organization as a general mental concept/process. The system and method claims do not describe any resultant action/step that is taken after the status information of the transport module is identified, much less how this identification relates to sample analysis. Thus, the control module does not add a meaningful limitation to the abstract idea. Furthermore, the “preparation device”, “transport device”, sealing device” and “analysis device” are recited at a high level of generality (as generic and well-known structures). The examiner further points to evidence that such an analysis systems and method are well-known, as disclosed in DeWitte et al., (US 2018/0372697). DeWitte discloses an assembled analysis system 10 comprising a preparation device (12; para [0099] et seq.), transport module 60 (see para [0112] et seq.), analysis module 14 (para [0099] et seq.), sealer (see para [106] et seq.) and computer with a software (Workflow Management System) integrated across all system components with an intuitive user interface (UI) for overall management of the analysis system. Guarracina et al., (US 2019/0242916) also teaches such analysis systems and methods are well-known as discussed below. The analyzing unit and necessary controlling of these elements as currently recited in the claims are well known and are not applied to any application, much less a practical application.
(b) The claims rely on mental processes to obtain/store/determine, thereby merely “applying” the organized concept (See MPEP 2106.05(f));
(c) Although the claims recite an analysis system/ control unit /software, the claims do not apply the exception, as the claim does not transform the analysis system to a different state or thing beyond its ordinary purpose (See MPEP 2106.05(f) and MPEP 2106.05(c)).
As such, the additional elements do not integrate the abstract idea into a practical application because they do not impose meaningful limits on practicing the abstract idea.
Because the claims fail under (2A), the claims are further evaluated under (2B). The claims herein do not include additional elements that are sufficient to amount to significantly more than the judicial exception under (2B) because, as discussed above with regard to integration of the recited abstract idea into a practical application, the examiner further points as evidence para [0081] of applicants’ corresponding US 2024/0230699 where it is conventional to use a monitoring method that may include polling and interrupt methods to detect delivery of the analytical sample vessel between the preparation device 1100 and analysis device 1200, which is performed manually by people at the time when these devices 1100 and 1200 were developed and approved. The generic computer elements (control module and software), do not provide an inventive concept as generic analyzing unit used with a computer is well-understood, routine and conventional. Further, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because (1) the analyzing unit, control unit and software are being used in their ordinary capacity and are merely tools to execute the abstract idea (See MPEP 2106.05(d)), (2) the additional claim elements in the dependent claims are mainly directed limitations as to how the status information is identified, whether considered individually or as a whole, do not meaningfully limit the judicial exception (See MPEP 2106.05(e)). Further, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. and generally link the abstract idea to a field of use (See MPEP 2106.05(h)), which are not particular practical applications. That is, the dependent claims 2-16 and 21-26 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the features represent an abstract idea and similarly do not integrate the exception into a practical application or include additional elements that amount to significantly more.
Lastly, MPEP 2106.04(a) details that the claims must reflect the disclosed improvement. Specifically MPEP 2106.05(a), 4th paragraph states the claim must include the components or steps of the invention that provide the improvement(s) described in the specification. Applicant’s specification states according to an embodiment of the present disclosure, the present disclosure provides an assembled analysis system that may be completed by adding an additional module to the RT-PCR device and the liquid handling device described above and assembling them, see para [0009]. Next, applicant’s specification at para [0010] states an embodiment of the present disclosure which enables a liquid handling device to determine a status of the aforementioned additional module using only a function already provided in the liquid handling device, that is, without adding new functions. These two disclosed improvement appear to contradict each other. The one embodiment adds an additional module to the preparation device and the transport module/analysis module, which would inherently include additional functions. Furthermore, the claims do not include any recitation that would determine the status of the additional module using only a function already provided in the liquid handling device (i.e., preparation device). The existing functions of the devices are not claimed. Nor do the claims recite which device/module is an additional device and how the additional functions therein interface with the already provided devices/modules in the system without adding additional functions. The examiner thinks that these steps maybe inherently part of using an API in the system control module, which is well known (see “What is an API?” article discussed further below). The claim recitations do not reflect any improvement over the known prior art.
Thus, in light of the above considerations the claims are non-statutory, and thus not patent eligible under 35 U.S.C. 101.
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 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.
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 1-17 and 20-26, as best understood, are rejected under 35 U.S.C. 103 as being unpatentable over Guarracina et al., (US 2019/0242916; hereinafter “Guarracina”) in view of “What is an API?” article; accessed on June 23, 2026 at https://www.postman.com/what-is-an-api/.
Regarding claim 1, Guarracina teaches an assembled analysis system 100 comprising:
a preparation device for preparing an analysis target sample in an analytical sample vessel (110/120, which may include, but are not limited to, electronic pipettes, microplate dispensers, media preparation modules (e.g., sterilization and dispensing of sample medium), environmental control modules (e.g., refrigeration, freezers, incubators, clean environments, hoods, etc.), storage modules, and centrifuges;
a transport module 500/600 for transporting the analytical sample vessel in which the analysis target sample is prepared (see para [0028] et seq., which teaches the at least one auto-navigating robotic processing vehicle 500, 600 may include a processing section that is configured to open the doors 300, 400 for providing the at least one auto-navigating robotic processing vehicle 500, 600 access to the stations and multi-axis robotic arm within the enclosure 314 so that the at least one auto-navigating robotic processing vehicle 500, 600 performs the process or preprocess condition at stations of the tools 200B, 200C); and
a system control module 999 including a driving software of the preparation device and configured to store a file in which status information of the transport module is recorded (register a location and configuration the preparation station and 110, 120 and status (e.g., operating, occupied, closed, etc.) thereof see para [0056] et seq.),
wherein the driving software includes a file reading application programming interface (API) 999a, see para [0054] et seq.), the driving software (API) reads the file stored in the system control module using the file reading API, and the status information is identified from the read file (location, configuration, status, etc.).
Note that an “Application Programming Interface (API)” is a defined set of rules and protocols that allows different software applications to communicate, exchange data, and use each other’s functionality without needing to understand the internal workings of the other system. How APIs work:
Client sends a request to an API endpoint (a specific URL).
The API processes the request, often interacting with a database or another service.
The server responds with the requested data or confirmation of an action.
The API returns this response to the client in a structured format (commonly JSON or XML)
APIs act as a bridge between a client (requesting application) and a server (providing application) to enable seamless integration and automation. APIs are well known in the art as the backbone of modern software ecosystems, powering everything from payment gateways to IoT devices, and are central to cloud-native and microservices architectures (see “What is an API?”). Thus, since Guarracina teaches the use of API in the system control module of an assembled analysis system, the API it would by definition read/store/ identify the status information of the different processing modules to determine their location, configuration, status, etc. for the expected advantage of providing seamless integration between the transport modules and other preprocess or process modules added to the system based on the identification of the transport module and the status of the processes in the process modules (see abstract). However, if it is determined that Guarracina does not teach the process steps performed by API in the system control module, then it would have been obvious to one of ordinary skill in the art at the time the claimed invention was effectively filed to provide the system control module with ability to perform these steps using an API for the known advantage of providing seamless integration between the transport modules and other preprocess or process modules based on the identification of the transport module and the status of the processes in the process modules (see What is an API?).
Regarding claims 2 and 21, this a functional/process limitation (the preparation device prepares the analysis target sample by dispensing at least one of a specimen and a reagent and accommodates the prepared analysis target sample in the analytical sample vessel) which does not limit the system claims. Also Guarracina teaches the transport device 500 capable to access both automation friendly devices (e.g., devices that have lab ware input/output positions and external control application processor interfaces (APIs) and non-automation friendly devices (such as manual devices generally operated by a human)), see para [0035] et seq.
The scope of the claims 3-10, 23, and 24, is/are unclear, but it appears that the information/status in the file of the system control module in Guarracina that would be accessible via the API.
Claims 11 and 25 recites wherein the preparation device detects whether the file is stored in the system control module using a polling method or an interrupt method. However, the specification does disclose these are steps performed manually by people at the time when these devices were developed and approved (see para [0081] et seq.). It is not clear how these manual steps performed by people are integrated with the system control module. It would have been obvious to one of ordinary skill to automate any manual activity performed by people for the expected benefit of less human error.
Claims 12 and 26 recite the preparation device is an approved device as an independently operated device. It is not clear from what is an “approved device” and how it relates to independently operated. However, Guarracina does teach the devices and their respective functions are automatically selectable to effect, independent of or in combination with vehicle travel, a preprocess or a preprocess condition of laboratory samples and/or sample holders with respect to a process at the at least one processing station (see para [0035] et seq.)
Regarding claims 13 and 20, Guarracina teaches a sealing device (e.g., capping device) controlled by the system control module and configured to seal an internal space of the analytical sample vessel against an outside of the analytical sample vessel, and the internal space accommodates the analysis target sample (see para [[0023] and [0039] et seq.)
As to claims 15, 16, 20, 22-23, Guarracina teaches an analysis device for performing an analysis operation on a target nucleic acid molecule for the analysis target sample ( a polymerase chain reaction, and the analysis operation includes an analysis for a result of the polymerase chain reaction), see para [0043] et seq.
Claim 21 is directed to a functional/process/intended use recitation, nevertheless, Guarracina teaches the preparation device prepares the analysis target sample by dispensing at least one of a specimen and a reagent, and accommodates the prepared analysis target sample in the analytical sample vessel (see para [0022] et seq.) Note that the analytical sample vessel, sample, and reagent are not positively recited as part of the assembled analysis system and therefore have not received patentable weight with respect to the art.
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure include:
i. Meece et al., (US 9,347,965) which teach an assembled analysis system including a main control unit with a processing circuit that communicates with various electronic modules using wireless communications signals, which allows for easy expansion of the capabilities of the basic autosampler unit. The main control unit resides on a longitudinal rail module that allows many various accessory modules to be physically mounted to the rail. There is a head module that includes the sampling syringe, and also includes transport motors that allow the head module to move in three axes. The head module includes its own processing circuit to control various solenoids and valves to properly move liquids and gasses for the sampling procedures, and to control the various transport motors via an API to automatically detect and calibrate the position of each of the accessory modules that are installed by a user on the rail module.
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/P. Kathryn Wright/Primary Examiner, Art Unit 1798
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