DETAILED ACTION
Comments
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
Claims 1-8 are pending and examined in the instant Office action.
Claim Interpretation
The following phrases recited in the claims are intended uses and do not differentiate the claims from the applied prior art.
In claim 1, “that characterizes molecular networks in complex systems using data analytics and contextual data to optimize sample collection strategies, to predict important molecular changes, and to confirm them with molecular measurements on obtained samples” are intended uses of the automated computer and fluidic system.
In claim 1, “for later assays” is an intended used of the stored samples.
In claim 1, “for teaching and research purposes” are intended uses of the software and databases.
In claim 4, “to optimize laboratory or on-chip analysis” is an intended use of the software controlling the specific reagents.
In claim 5, “used extensively on sample contacting surfaces to prevent sample adsorption and absorption” is an intended use of the superhydrophilic chemistry.
In claim 6, “for mass spectrometry of lipids and metabolites” are intended uses of EDTA.
In claim 6, “to reduce sample contamination by dissolved gasses or sample volume loss by evaporation” is an intended use of the surface coatings.
In claim 7, “to allow linear filling of sample storage devices to optimize sample filling and emptying avoiding bubbles and sample break up” is an intended use of the tubular geometry.
In claim 7, “allowing flow rate calculation and time stamping of sample start and end times for each sample,” are intended uses of the sensors.
In claim 7, “to allow automated surface chemistry deposition, and efficient sample removal by automated, high throughput devices” is an intended use of the placement of ports.
In claim 8, “to detect system component failure” is an intended use of the computer software that tracks sample movement and other performance metrics.
In claim 8, “to prevent sample spoilage, along with issuing warnings when temperature exceeds a safe limit” are intended uses of the refrigeration module.
Claim Comments - 35 USC § 112(f) - Means plus function
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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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. Such claim limitation(s) is/are: “refrigeration module” in claim 8.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (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) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Paragraph 56 of the specification gives structural support for the refrigeration module.
Claim Rejections - 35 USC § 112(b) - Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “important” in claim 1 is a relative term which renders the claim indefinite. The term “important” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear as to relative to what distinguishes important molecular changes from insignificant molecular changes.
Claim 1 recites the limitation "them" in line 3. There is insufficient antecedent basis for this limitation in the claim. It is unclear as to what the pronoun “them” refers. For the purpose of examination, “them” refers to molecular changes.
While the core of claim 1 is drawn to the automated computer and fluidic system, the final limitation of claim 1 recites software that stores and analyzes molecular dynamics databases. It is unclear as to the role of this software in the fluidic system. In other words, the claim is missing a step connecting the fluidic system to the software.
While claim 1 recites annotating a timeline with events of interest and decisions made, it is unclear as to the metes and bounds of a qualifying event and/or decision to be annotated on the timeline.
While claim 2 recites networked computers for obtaining contextual data that “may include, but not be limited to, connections with databases, the edge computing environment, cloud computing, Internet of Things (IoT) devices, smart devices, smart phones, and sensors for data input”, it is unclear as to whether these optional limitations are required. For the purpose of examination, it is interpreted that the optional limitations are not required.
While claim 2 recites other network connections to smart devices “may include, but not be limited to, patient support services such as mechanical ventilators, intravenous pumps, cardiac monitors, pulse oximeters, dialysis and extracorporeal membrane oxygenators, hospital bed sensors, patient attached sensors, cardiac assist devices”, it is unclear as to whether these optional limitations are required. For the purpose of examination, it is interpreted that the optional limitations are not required.
Regarding claim 2, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
In claim 2, it is unclear if the list “mechanical ventilators, intravenous pumps, cardiac monitors, pulse oximeters, dialysis and extracorporeal membrane oxygenators, hospital bed sensors, patient attached sensors, cardiac assist devices” is in the alternative. For the purpose of examination, it is interpreted that this list is in the alternative.
While claim 3 recites data analytic approaches to be tested that “may include, but not be limited to, artificial intelligence programs, big data algorithms, dynamic network analysis, clustering techniques, predictive modeling based on both initial and updated conditions, Bayesian and other statistical methods”, it is unclear as to whether these optional limitations are required. For the purpose of examination, it is interpreted that the optional limitations are not required.
While claim 3 recites samples and contextual data that “may be based on multi-criteria decision-making or other algorithms”, it is unclear as to whether these optional limitations are required. For the purpose of examination, it is interpreted that the optional limitations are not required.
Regarding claim 4, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is unclear if LOC, POC, and other real time analyzers are required or optional. For the purpose of examination, it is interpreted that these limitations are optional.
It is unclear from claim 4 as to the unabbreviated form of LOC and POC.
Claim 4 recites the limitation "the results of real time assays" in line 8. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, it is interpreted that this phrase signifies any results of real time assays.
While claim 4 recites incorporating into a timeline with results and decisions made, it is unclear as to the metes and bounds of a qualifying result and/or decision to be annotated on the timeline.
The term “active” in claim 5 is a relative term which renders the claim indefinite. The term “active” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear to what conditions make the valves active as opposed to inactive.
Claim 5 recites the limitation "this chemistry" in line 9. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, it is interpreted that this chemistry corresponds to superhydrophilic chemistry.
The term “highly absorbent” in claim 5 is a relative term which renders the claim indefinite. The term “highly absorbent” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear to what conditions make material highly absorbent as opposed to not highly absorbent.
Regarding claim 6, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is unclear if trehalose, sample optimizers, EDTA are required or optional. For the purpose of examination, it is interpreted that these limitations are optional.
Regarding claim 6, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is unclear if EDTA is required or optional. For the purpose of examination, it is interpreted that EDTA is optional.
In claim 6, it is unclear as to whether the list, “protease, DNase, RNase inhibitors, anti-oxidants, anticoagulants, cryoprotectants” is in the alternative. For the purpose of examination, it is interpreted that the embodiments of this list are recited in the alternative.
The terms “strategically placed sensors” and “strategic placement of ports” in claim 7 are relative terms which renders the claim indefinite. The terms “strategically placed sensors” and “strategic placement of ports” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear as to the metes and bounds of strategic versus not strategic placement comprises.
The term “safe” in claim 8 is a relative term which renders the claim indefinite. The term “safe” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear as to what constitutes a safe as opposed to an unsafe limit.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kimmerling et al. [US PGPUB 2020/0227168 A1] in view of Giusti et al. [US PGPUB 2019/0147989 A1] in view of Jacobs et al. [US PGPUB 2016/0132375 A1].
Claim 1 is drawn to an automated computer and fluidic system. The system comprises a networked computer that gathers contextual data assay results and updated predictive models. The system comprises automated fluidic sampling components that store samples and run real time assays. The system comprises software controlled valves that split sample streams among storage and assay devices. The system comprises software that creates and stores contextually annotated molecular dynamics databases and constructs an annotated timeline.
The document of Kimmerling et al. studies machine learning in functional cancer assays [title]. Figure 8 of Kimmerling et al. illustrates a networked computer connected to (and with software controlling) smart devices. Figure 6 and paragraph 72 of Kimmerling et al. illustrates a fluidic system that splits streams between a real-time assaying device and a storage device.
Kimmerling et al. does not teach predictive models. Kimmerling et al. does not teach software that creates and stores contextually annotated molecular dynamics databases and constructs an annotated timeline.
The document of Giusti et al. studies integrating molecular, omics, immunotherapy, metabolic, epigenetic, and clinical databases [title]. Figure 6 of Giusti et al. illustrates a data flow diagram comprises molecular dynamics databases.
Kimmerling et al. and Giusti et al. do not teach predictive models or an annotated timeline.
The document of Jacobs et al. studies a method doe detecting the impending analytical failure of networked diagnostic clinical analyzers [title]. Figure 8 of Jacobs et al. illustrates an assay predictive alert control chart. Figure 8 of Jacobs et al. is an annotated timeline that predicts failure by sending alerts when the operational composite statistic crosses a threshold.
With regard to claim 2, Figure 8 of Kimmerling et al. illustrates a networked computer connected to smart devices.
With regard to claim 3, Figure 6 of Giusti et al. illustrates data analytics and decision software. Figure 8 of Jacobs et al. comprises a decision of whether to send an alert.
With regard to claim 4, Figure 8 of Kimmerling et al. illustrates a computer with software that controls and receives results of real-time assays involving control valves and sample streams. Figure 8 of Jacobs et al. illustrates a timeline and comprises a decision of whether to send an alert.
With regard to claim 5, Figure 8 of Kimmerling et al. illustrates a computer with hardware controlling valves. Figure 7 and paragraph 75 of Kimmerling et al. teach sample biomolecules absorbed on a microarray. Figure 5 and paragraph 63 of Kimmerling teach storage of samples for superhydrophilic chemistry in superhydrophobic Eppendorf tubes with passive, hydrophobic valves.
With regard to claim 6, paragraph 103 of Giusti et al. teaches addition of proteases and RNases to a biological sample for cell lysis and to remove RNA. Figure 6 of Kimmerling illustrates analyzing data with separate streams. Figure 5 of Kimmerling et al. illustrates using Eppendorf tubes in bulk to limit diffusion of gas and vapor.
With regard to claim 7, Figure 5 of Kimmerling et al. illustrates using Eppendorf tubes as storage devices. Figure 6 of Kimmerling illustrates placing sensors to assay liquids flowing through a tubular geometry with ports.
With regard to claim 8, Figure 8 of Jacobs et al. illustrates an assay predictive alert control chart. Figure 8 of Jacobs et al. predicts failure by sending alerts when the operational composite statistic crosses a threshold. Paragraph 105-107 of Giusti et al. teach refrigerating/cooling the samples.
It would have been obvious to someone of ordinary skill in the art at the time of the effective filing date of the instant application to modify the software and fluidic system of Kimmerling et al. by use of the databases of Giusti et al. wherein the motivation would have been that the databases give additional information that facilitate understanding of molecular properties in the fluidic assays [abstract of Giusti et al.].
It would have been obvious to someone of ordinary skill in the art at the time of the effective filing date of the instant application to modify the software and fluidic system of Kimmerling et al. and the databases of Giusti et al. by use of the assay predictive alert chart of Jacobs et al. wherein the motivation would have been that the data of Jacobs et al. warn users of devices of failure before the device actually fails [paragraph 66 and Figure 8 of Jacobs et al.].
E-mail Communications Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Russell Negin, whose telephone number is (571) 272-1083. This Examiner can normally be reached from Monday through Thursday from 8 am to 3 pm and variable hours on Fridays.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s Supervisor, Larry Riggs, Supervisory Patent Examiner, can be reached at (571) 270-3062.
/RUSSELL S NEGIN/Primary Examiner, Art Unit 1686 19 September 2025