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 .
Response to Arguments
Regarding claim 1, Applicant’s amendments overcome the previous 102 rejections to claim 1. Therefore, the previous 102 rejections of claim 1 has been withdrawn.
Regarding claim 20, Applicant’s arguments see pages 21-28, filed 6/30/2026, have been fully considered and are persuasive. The corresponding 103 rejections of claims 20-23 have been withdrawn.
Regarding claim 7, Applicant appears to argue that it would not be obvious to modify a disposable chip by having an autosampler, as the chip must be replaced after each use; therefore, using it to measure multiple samples would undermine the simplicity of the chip taught by Takenaka. Additionally, Applicant appears to argue that neither Takenaka nor Wilson provides any teaching, suggestion, or rationale for such a modification.
As the examiner fully considered Applicant’s arguments, the examiner did a review of the prior art to evaluate Applicant’s arguments in light of the level of ordinary skill in the art as it relates to disposable chips and autosamplers. The examiner did not find any teaching away of combining autosamplers and disposable chips, or in modifying them to be used together. In contrast, the examiner found that they are indeed used together in the prior art. For example, Hart (US 20210121878 A1) reads, "[0057] In an alternative embodiment, the devices and methods of the invention may comprise particle or cellular analysis occurring on-chip in a separate region of the autosampler dedicated for Raman analysis. Various configurations of the device may be appropriate depending on the purpose and functionality of the task… In certain embodiments, a disposable chip with regions for 96 samples to collect and be measured may be used."
112f -- 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 following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(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) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) 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: pressurized gas delivery system in claims 1-9 and 12-18; light focusing element and light detection system in claims 12-13 and 22-23; and heating unit in claim 18.
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.
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 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Takenaka (US 20080153153 A1; cited by Applicant) in view of Wilson (US 20170138835 A1).
Regarding claim 7, Takenaka teaches a flow cytometry evaluation system, comprising:
a flow cytometry investigation system (paragraphs 78-79 and 152-153) comprising an investigation zone (18) configured to receive during a flow cytometry evaluation a flow of a fluid sample (paragraphs 59-61);
a sample effluent system (paragraphs 78-79), comprising:
an effluent collection vessel (163) with an effluent fluid inlet to receive an effluent of the fluid sample exiting the investigation zone (18) during a flow cytometry evaluation (paragraphs 78-79), and
an effluent fluid conduction path from the investigation zone (18) to the effluent fluid inlet (figures 5 and 9-10; path from 18 to 163); and
a pressurized gas delivery system (14) in fluid communication with the sample effluent system, wherein the pressurized gas delivery system is configured to apply pressurized gas to pressurize at least a portion of the sample effluent system to impede fluid flow through the effluent fluid conduction path toward the effluent fluid inlet during a flow cytometry investigation (paragraphs 72-76 explain the pressure is pressurized air which is pressurized gas; and paragraphs 64-65 explain 158 is an air flow path; regarding impede fluid flow, note that it impedes flow in both directions at different times as explained in paragraphs 78-79 and figures 9-10; this is while the flow is in and through the investigation zone and therefore during the investigation, as explained in the examiner’s comments).
a fluid sample conduction path to the investigation zone to provide the fluid sample to the investigation zone for the flow cytometry investigation, wherein the fluid sample conduction path, the investigation zone, the effluent fluid conduction path and the effluent collection vessel are configured to comprise a pressurized fluidics system during the flow cytometry investigation (figures 5, 9, and 10 and paragraphs 64 and 75-79).
Takenaka doesn’t explicitly teach an autosampler configured to receive a plurality of the fluid samples contained in a plurality of sample containers and to deliver the plurality of the fluid samples to the fluid sample conduction path for flow cytometry evaluation.
Like Takenaka (and like Applicant), Wilson is directed to a flow cytometry system and teaches an autosampler configured to receive a plurality of the fluid samples contained in a plurality of sample containers and to deliver the plurality of the fluid samples to the fluid sample conduction path for flow cytometry evaluation (paragraphs 4 and 17). Additionally, Wilson teaches this provides the benefit of increasing the number of samples that can be processed (paragraph 4) while properly utilizing space (paragraphs 5-6).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the above combination such that it comprises an autosampler configured to receive a plurality of the fluid samples contained in a plurality of sample containers and to deliver the plurality of the fluid samples to the fluid sample conduction path for flow cytometry evaluation in order to increase the number of samples that can be processed while properly utilizing space.
For the level of ordinary skill in the art, see the additional prior art below, such as Hart (US 20210121878 A1).
Regarding claim 8, the above combination comprises a housing in which the flow cytometry investigation system and the autosampler are disposed in a stacked relationship, wherein the first stack location is in a first compartment within the housing with the autosampler disposed therein and the second stack location is in a second compartment within the housing with the flow cytometry investigation system disposed therein, and wherein the second compartment is disposed below the first compartment (Wilson, figure 1, where the flow cytometer investigation system is 102 and the autosampler is 104 as explained in paragraphs 16-17; housings and stacked relationship is visible in the figures).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Takenaka and Wilson, as applied to claim 7 above, and further in view of Sklar (US 20020170365 A1)
Regarding claim 9, in the above combination the autosampler comprises a sample receiving location configured to receive a plurality of sample containers containing a plurality of the fluid samples for flow cytometry evaluation, the autosampler comprises a sample delivery probe configured to withdraw the fluid samples from the sample containers for delivery to the investigation zone for flow cytometry evaluation (Wilson, figure 1 and paragraphs 18-19).
The above combination doesn’t explicitly teach and the sample receiving location is disposed higher in elevation than a highest elevation in the investigation zone.
Like Takenaka (and like Applicant), Sklar is directed to flow cytometry and teaches the autosampler comprises a sample receiving location configured to receive a plurality of sample containers containing a plurality of the fluid samples for flow cytometry evaluation, the autosampler comprises a sample delivery probe configured to withdraw the fluid samples from the sample containers for delivery to the investigation zone for flow cytometry evaluation and the sample receiving location is disposed higher in elevation than a highest elevation in the investigation zone (figure 1A; paragraphs 43 and 47).
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It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the above combination such that the autosampler comprises a sample delivery probe configured to withdraw the fluid samples from the sample containers for delivery to the investigation zone for flow cytometry evaluation and the sample receiving location is disposed higher in elevation than a highest elevation in the investigation zone – in order to have high throughput in a system that is adapted to the environmental restrictions of the user.
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Allowable Subject Matter
Claims 1-6, 12-18, and 20-23 are allowed.
The following is an examiner’s statement of reasons for allowance:
Regarding claims 1-6 and 12-18, the prior art of record (taken alone or in combination) fails to anticipate or render obvious, “a pressurized gas delivery system in fluid communication with the sample effluent system, wherein the pressurized gas delivery system is configured to apply pressurized gas to pressurize at least a portion of the sample effluent system to impede fluid flow through the effluent fluid conduction path in a direction from the investigation zone toward the effluent fluid inlet while the fluid sample is flowing through the investigation zone during a flow cytometry investigation,” in combination with the other claimed limitations.
Regarding claims 20-23, the prior art of record (taken alone or in combination) fails to anticipate or render obvious, “applying pressurized gas to pressurize at least a portion of the sample effluent system to impede fluid flow through the effluent fluid conduction path toward the effluent fluid inlet of the effluent collection vessel.,” in combination with the other claimed limitations.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Additional Prior Art
Hart (US 20210121878 A1) reads, "[0057] In an alternative embodiment, the devices and methods of the invention may comprise particle or cellular analysis occurring on-chip in a separate region of the autosampler dedicated for Raman analysis. Various configurations of the device may be appropriate depending on the purpose and functionality of the task… In certain embodiments, a disposable chip with regions for 96 samples to collect and be measured may be used."
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUFUS L PHILLIPS whose telephone number is (571)270-7021. The examiner can normally be reached M-Th, 2 -10 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michelle Iacoletti can be reached at (571) 270-5789. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RUFUS L PHILLIPS/ Examiner, Art Unit 2877
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