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 .
Priority
The present application filed on 04/24/2024, claims priority to European Patent Application No. EP23170762, filed on 04/28/2023.
The content of this application are supported in the original disclosure provided in European Patent Application No. EP23170762, filed on 04/28/2023, thus instant claims 1-8,10-14 and 16-22 have an effective filing date of 04/28/2023.
Information Disclosure Statement
One Information Disclosure Statement(s) (IDS), filed on 02/10/2025, is acknowledged and considered.
Claim Status
Claims 1-8, 10-14 and 16-22 are pending. Claims 9 and 15 are cancelled. Claims 1-8, 10-14 and 16-22 are examined herein below.
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: “the reaction unit is configured for conjugating said detection agent with the indicator agent” in claim 10. The instant Specification defines the reaction unit “in an embodiment” comprises “a first reaction vessel…a pipetting mechanism” and “in an embodiment comprises a multitude of reaction vessels and corresponding pipetting mechanism” (instant Specification, pg. 18, lines 20-30).
Further, claim limitation(s) “labeling unit is configured to contact a sample with the conjugation product” in claim 10. The instant Specification defines the labeling unit “in an embodiment comprises a reaction vessel, e.g. a second reaction vessel as described herein above, and a pipetting mechanism allowing the transfer of a sample and/or at least one conjugate into said reaction vessel” and “[d]epending on the type of labeling performed, the labeling unit may comprise further elements, such as a magnet for performing magnetic bead assisted cell sorting or for immobilizing a complex comprising the detection agent, the indicator agent, and the analyte…herein, the term labeling unit relates to any unit adapted for contacting a conjugate as specified herein above with a sample, in an embodiment allowing formation of a complex comprising the analyte, the detection agent, and the indicator agent” (instant Specification, pg. 19, lines 1-12).
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 § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5 and 20 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Lim et al., (Lim et al., WO 2014/196803 Al, Date: 12/11/2024).
Throughout the disclosure Lim teaches a strip for rapid testing, a diagnostic kit, and a method for qualitative or quantitative analysis of an analyte in a sample. Lim teaches the diagnostic kit comprises a strip for rapid testing. Lim teaches the strip for rapid testing comprises a variable control line to overcome hook effect, which normally makes quantitative analysis difficult on test strips. Lim further teaches that presence of a variable control line on the strip enables highly reliable quantitative and qualitative analysis of analyte with the naked eye.
Regarding claim 1, Lim teaches a method for labeling an analyte in a sample, said method comprising: (a) providing a detection agent binding to the analyte and conjugating said detection agent with an indicator agent to produce a conjugation product; and (b) contacting said sample with said conjugation product of step (a); wherein said step (b) is performed directly after completion of step (a) and wherein steps (a) and (b) are performed by the same labeling device (pg. 3, para 8).
Regarding claim 2, Lim teaches a rapid test strip, which in the art is understood to mean that the total assay time would necessarily and inevitably be completed in at most 1 day. Thus, using the broadest reasonable interpretation, Lim teaches method of claim 1, wherein performing directly comprises performing step (b) at most 1 day after completion of step (a) [pg. 3, para 8; and pg. 1, para 1].
Regarding claim 4, Lim teaches the method of claim 1, wherein said detection agent is an antibody or fragment thereof (pg. 4, para 24; pgs. 7-8, para 61).
Regarding claims 5 and 20, Lim teaches the method of claim 1, wherein said sample is a biological sample and wherein said sample comprises cells (pgs. 9-10, para 72; and pg. 17, para 116).
Regarding claim 6, Lim teaches the method of claim 1, wherein the coupling between the detection agent and the indicator agent is non-covalent (pg. 7, para 58, passive adsorption = non-covalent).
Claim(s) 10-11 and 13-14 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Flore et al., (Flore et al., The Abbott IMx™ Automated Benchtop Immunochemistry Analyzer System, 1988, Clin. Chem, 34, 9, 1726-1732).
Throughout the disclosure, Flore teaches a clinical instrument called the Abbott IMx™ used to perform automated immunoassay testing. Flore teaches the instrument comprises a reaction unit, a first and second containers, and a labeling unit. Flore teaches the reaction cell comprises reaction vessels and/or containers and an automated pipetting mechanism/system. Flores teaches the device comprises a processor, and an analysis unit comprising a fluorescence-based detector.
Regarding claim 10, Flore teaches a labeling device comprising: (A) a first container comprising a detection agent, operably connected to a reaction unit; (B) a second container comprising an indicator agent, operably connected to the reaction unit, and (C) a labeling unit; wherein the reaction unit is configured for conjugating said detection agent with the indicator agent to produce a conjugation product, and wherein said labeling unit is configured to contact a sample with the conjugation product, wherein said labeling device further comprises a processor and tangibly embedded instructions which, when performed on the processor, cause the labeling device to perform the method of claim 1 (pg. 1726, full para 7; pgs. 1727-1728; pg. 1727, Figs. 1, 2a, 2b; pgs. 1727 and 1730 containers and reaction unit operably connected through pipette system/fluid delivery; 1st container = sample well; reaction unit = reaction well or reaction cell; 2nd container = predilution well; and labeling unit = capture surface).
Regarding claim 11, Flore teaches the labeling device of claim 10, further comprising an analysis unit comprising a detector (pgs. 1726-1727, “Apparatus;” pg. 1728, Fig. 3; and pg. 1729).
Regarding claim 13, Flore teaches the labeling device of claim 10, further comprising a selector unit comprising tangibly embedded an algorithm for selecting an indicator agent for conjugation with a detection agent (pg. 1728, full paras 1-5).
Regarding claim 14, Flore teaches a system comprising, operably connected, (i) a labeling device according to claim 10; and (ii) a detection device and/or a selector device (pg. 1726, full para 7; pgs. 1727-1728; and Figs. 1, 2a, 2b).
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.
Claim(s) 3, 7, 16-19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Lim et al., (Lim et al., WO 2014/196803 Al, Date: 12/11/2024), as applied to claim 1 above, and further in view of Chen, (US 2015/0111776 A1, Pub. Date: 04/23/2015).
Regarding claim 3, the teaching of Lim are discussed herein above. Lim teaches the method of claim 1. Lim does not teach wherein the conjugating step (a) is performed in a first reaction vessel and wherein performing directly comprises contacting the conjugate from step (a) with the sample in a second reaction vessel, wherein the conjugate from step (a) is not contacted to any further vessel before step (b).
Throughout the disclosure, Chen teaches immunoassay methods and kits comprising one or more over-labeled fluorescent probes for detecting and quantifying of one or more target analytes present in a sample. Chen teaches embodiments with multiplexing formats with low cross-reactivity.
Chen teaches wherein the conjugating step (a) is performed in a first reaction vessel and wherein performing directly comprises contacting the conjugate from step (a) with the sample in a second reaction vessel, wherein the conjugate from step (a) is not contacted to any further vessel before step (b) [paras 0103-0105].
Regarding claim 7, Lim teaches the limitations of claim 1. Lim does not teach an additional step (a1) providing an additional detection agent binding to an additional analyte and an additional agent with an additional indicator to produce an additional conjugation product, wherein step (b) comprises contacting said sample with the conjugation product of step (a), and with said additional conjugation product of step (a1), and wherein step (b) is performed directly after completion of at least one of said providing and conjugating steps.
Chen teaches wherein said method comprises an additional step (a1) of providing an additional detection agent binding to an additional analyte, an additional step of conjugating said additional detection agent with an additional indicator agent to produce an additional conjugation product, wherein step (b) comprises contacting said sample with the conjugation product of step (a), and with said additional conjugation product of step (a1), and wherein step (b) is performed directly after completion of at least one of said providing and conjugating steps (paras 0103-0105, 0110-0111, and 0112).
It would have been prima facie obvious, at the time of filing, to combine the method of labeling an analyte as taught by Lim with the method for preparing the conjugation step in a first vessel and mixing or contacting with a sample in second vessel and further comprising an additional step (a1), as taught in separate embodiments by Chen. A skilled artisan would have been motivated to combine these teachings because it would enable multiplexing for detecting more than one target analyte while reducing cross-reactivity. At the time of filing, a person having ordinary skill in the art would have a reasonable expectation of success because combining these teachings amounts to combining known elements/ components according to known methods, where each element/component is known to function the same separately as they do when combined, to yield expected and predictable results.
Regarding claims 16-19, Lim teaches the limitations of claim 1. Lim does not teach performing directly comprises performing step (b) at most 12 h, 6 h, 3 h, and 1 h after completion of step (a).
However, Chen teaches wherein performing directly comprises performing step (b) at most 12h after completion of step (a) [claim 16]; performing directly comprises performing step (b) at most 12h after completion of step (a) [claim 17]; performing directly comprises performing step (b) at most 3h after completion of step (a) [claim 18]; and performing directly comprises performing step (b) at most 1h after completion of step (a) [claim 19] (paras 0003-0004 and 0112).
It would have been prima facie obvious, at the time of filing, to combine the method of labeling an analyte as taught by Lim with the method for detecting analytes by contacting sample with conjugate products with total assay time ranging between 20-120 minutes, as taught by Chen. A skilled artisan would have been motivated to combine these teachings because it would result in a method that is rapid, accurate, and quantitative. The total assay time range taught by Chen overlaps with the timing for performing step (b) after step (a) in the claimed invention, thus, a skilled artisan would have been motivated to try a finite number of timepoints within the range and close to the range taught by Chen in order to determine the optimal time required to arrive at the claimed invention. At the time of filing, a person having ordinary skill in the art would have a reasonable expectation of success because combining these teachings amounts to combining known elements/ components according to known methods, where each element/component is known to function the same separately as they do when combined, to yield expected and predictable results.
Regarding claim 21, Lim teaches the limitations of claim 6. Lim does not teach coupling between the detection agent and the indicator agent is via an affinity pair.
Chen teaches wherein the coupling between the detection agent and the indicator agent is via an affinity pair (paras 0016, 0089, and Fig. 3).
It would have been prima facie obvious, at the time of filing, to combine the method of labeling an analyte as taught by Lim with the method for detecting analytes comprising a conjugate product coupled via an affinity pair, as taught by Chen. A skilled artisan would have been motivated to combine these teachings because a conjugate product coupled via an affinity pair would result in amplification of the analyte detection signal. At the time of filing, a person having ordinary skill in the art would have a reasonable expectation of success because combining these teachings amounts to combining known elements/ components according to known methods, where each element/component is known to function the same separately as they do when combined, to yield expected and predictable results.
Claim(s) 8 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Lim et al., (Lim et al., WO 2014/196803 Al, Date: 12/11/2024), as applied to claim 1 above, and further in view of Lambert et al., (US 20050250141A1, Pub. Date: 11/10/2005).
Regarding claim 8, the teachings of Lim are discussed herein above. Lim teaches all the limitations of claim 1. Lim does not teach wherein said method comprises selecting the indicator agent and additional indicator agent, and optionally any further indicator agent, such that interference between said indicator agents is reduced.
Throughout the disclosure Lambert teaches multiplexed lateral flow assays, related methods, and devices for simultaneous detection of multiple analytes present in a sample. Lambert teaches an embodiment wherein the immunoassay comprises three different target analytes with three corresponding detection agents. Lambert teaches each detection agent is conjugated to an indicator agent or label. Lambert teaches each indicator agent or label is spectrally distinct, reducing interference between indicator agents.
Lambert teaches wherein said method comprises selecting the indicator agent and additional indicator agent, and optionally any further indicator agent, such that interference between said indicator agents is reduced (para 0064 and Fig. 2).
Regarding claim 22, Lim teaches all the limitations of claim 1. Lim does not teach wherein said interference, of claim 8, is selected from the group consisting of fluorescence spillover, overlap of absorption spectra, and cross-excitation.
Lambert teaches wherein said interference is selected from the group consisting of fluorescence spillover, overlap of absorption spectra, and cross-excitation (para 0064 and Fig. 2).
It would have been prima facie obvious, at the time of filing, to combine the method taught by Lim with the teachings of using indicator agents/labels with non-overlapping fluorescent emission spectra, as taught by Lambert. A skilled artisan would have been motivated to combine these teaching and modify the method taught by Lim because using two or more conjugation products with each comprising a detection agent conjugated to different indicator agents with non-overlapping, or non-interfering, absorption and emission spectra would enable detection of two more distinct analytes, enabling multiplexing capabilities. At the time of filing, a person having ordinary skill in the art would have a reasonable expectation of success because combining these teachings amounts to combining known elements/ components according to known methods, where each element/component is known to function the same separately as they do when combined, to yield expected and predictable results.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Flore et al., (Flore et al., The Abbott IMx™ Automated Benchtop Immunochemistry Analyzer System, 1988, Clin. Chem, 34, 9, 1726-1732), as applied to claims 10 and 11 above, and further in view of Antfolk et al., (Antfolk et al., Continuous flow microfluidic separation and processing of rare cells and bioparticles found in blood -A review, 2017, Analytica Chimica Acta, 965, 9-35)
Regarding claim 12, the teachings of Flore are discussed herein above. Flore teaches the labeling device of claim 10 and 11. Flore does not teach the detector comprises a FACS unit or a digital imaging unit.
Throughout the review article, Antfolk teaches the state of the art, at the time of filing, regarding advances in continuous flow microfluidic cell separation and processing, including fluorescence activated cell sorting (FACS). Antfolk teaches FACS is commonly used for cell sorting applications. Antfolk further teaches advantages of FACS includes the ability to sort cells base on more than one marker simultaneously.
Antfolk teaches a FACS unit (pg. 11, section 2.1.).
It would have been prima facie obvious, at the time of filing, to combine the labeling device as taught by Flore with the FACS unit taught by Antfolk. A skilled artisan would have been motivated to combine and modify the detector in the device taught by Flore with addition of a FACS unit, as taught by Antfolk, because it would enable sorting of cell samples based on phenotypical differences through expression of specific biomarkers and a FACS unit would further enable comprehensive sample characterization such as providing information regarding the number of cells expressing a specific marker and levels of expression for each cell. At the time of filing, a person having ordinary skill in the art would have a reasonable expectation of success because combining these teachings amounts to combining known elements/ components according to known methods, where each element/component is known to function the same separately as they do when combined, to yield expected and predictable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA L LIRIANO-NG whose telephone number is (571)272-0085. The examiner can normally be reached Monday-Friday, 7:30 am-3:30 pm (EST).
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/MELISSA LIZETTE LIRIANO-NG/Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 July 29, 2026
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