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 .
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.
Priority
The present application is indicated to be a continuation of application 16/561,284, filed 09/05/2019. Application 16/561,284 is a divisional of 14/968,118, filed 12/14/2025 (US Patent No. 10,422,797), which is filed as a continuation of PCT/EP2014060149, filed 05/16/2014. Acknowledgment is also made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d) to Application No. 13172826.3, filed on 06/19/2013 in the European Patent Office.
This application repeats a substantial portion of prior Application No. 16/561,284, filed 09/05/2019, and adds disclosure not presented in the prior application (see for example, claim 1 of the present application recites “rotation frequency of the stirring unit is maximally high but below a frequency that causes foaming”, “maximally high” is not supported by the prior filed application(s). The prior application (16/561,284) supports at page 8 that “The applied rotational frequency should be high enough to provide for short time periods for stirring the fluid. However, the rotational frequency should not be too high, because a too high rotational frequency might cause foam generation which in turn may lead to unwanted effects”. However, “maximally high” as recited at the claims is broader in scope and is not limited to merely maximally high as in high enough to provide for short time periods for stirring while not a frequency that causes foam).
Because this application names the inventor or at least one joint inventor named in the prior application, it may constitute a continuation-in-part of the prior application. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
As a result, the effective filing date of the claimed invention is 04/14/2023.
Information Disclosure Statement
The information disclosure statement (IDS) filed 04/14/2022 is considered, initialed and is attached hereto.
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:
“stirring unit” in method claims 1, 4 and 15.
See also analysis system (product) claim 12, “stirring unit for stirring a fluid comprising a fluid comprising a protein coated magnetic microparticles provided in a receptacle”.
In the present case, the corresponding structure, in light of the originally filed specification, for a “stirring unit” is described as a stirrer mounted on a shaft that is driven by a motor (see for example, Figure 5 and para [0084]).
As a result, the claim limitation “a stirring unit” when read in light of the specification connoted sufficient, definite structure.
“a measuring unit being operable to generate a signal indicative of an amount of fluid in the receptacle” in claim 12
Regarding “a measuring unit”, the corresponding structure described in the specification is a capacitor sensor (para [0038]).
As a result, the claim limitation “a measuring unit” when read in light of the specification connoted sufficient, definite structure.
“a trigger component for applying the excitation energy for causing the luminescence” in claim 12
Regarding “a trigger component” , the corresponding structure is described in the specification is at paras [0048]-[0049] and is a voltage source that applies a voltaic trigger pulse on the working electrode.
As a result, the claim limitation “a trigger component” when read in light of the specification connoted sufficient, definite structure.
“an acquisition component for measuring the luminescence …being operable to provide a measurement signal” in claim 12
Regarding “an acquisitions component”, the corresponding structure is described at pages 11 and 13 of the specification and is an optical detector comprising a photomultiplier.
As a result, the claim limitation “an acquisition component” when read in light of the specification connoted sufficient, definite structure.
“a magnetic component” in claim 10
Regarding “a magnetic component”, the corresponding structure is a permanent magnet (para [0047]).
As a result, the claim limitation “a magnetic component” when read in light of the specification connoted sufficient, definite structure.
“an extraction component” in claim 12
Regarding “an extraction component”, the corresponding structure is a pipetting probe (e.g., paras [0037]-[0038] ).
As a result, the claim limitation “an extraction component” when read in light of the specification connoted sufficient, definite structure.
“a data processing unit” for receiving the first signal and a second signal indicative of rotation frequency appropriate for the amount of fluid, claim 4. See at claim 5, the data processing unit further “in response to receiving the first signal looks up the table for the rotational frequency appropriate for the amount of fluid the first signa is indicative of and provides a second signal being indicative of the rotational frequence appropriate for the amount of fluid”.
See further claim 5 recites some structure, “the data processing unit comprises a table, the table comprising information indicative of which rotational frequency to sue for a defined amount of fluid”.
Further see claim 12, “a data processing unit being adapted to:
determine a rotational frequency for the stirring unit using the signal indicative of the amount of fluid in the receptacle, the rotational frequency being proportional to the amount of fluid,
control the stirring unit to stir the fluid for a predefined period of time by applying
the previously determined rotational frequency, the predefined period of time being held
constant for each stirring process, wherein the stirring is performed for homogenization
and disaggregation of the microparticles, wherein the rotational frequency of the stirring
unit is maximally high but below a frequency that causes foaming,
generate an output signal being indicative of the presence of the analyte in the
liquid sample using the measurement signal”; and claim 13 “the data processing unit is further operable to access the database and look up table for the rotational frequency appropriate for the amount of fluid signal is indicative of”.
Regarding a data processing unit, the data processing unit is described at paras [0039]-[0042], however the specification merely describes what it does and no structure specific to describe the structure for it. See this limitation addressed further below under 35 U.S.C. 112(b).
Claim Objections
Claims 1-4, 12 and 14-15 are objected to because of the following informalities:
Claims 1 and 14 recite “acquiring a signal being indicative of an amount of the fluid”, it is suggested that Applicant amend in order to recite “acquiring a signal indicative of the fluid amount contained in the receptacle” in order to omit the improper use of the present participle “being”. Typically, “being” is reserved for forming continuous tenses, used alone in nonfinite clauses and used as an adjective.
This is similarly the case regarding the limitation “generating an output signal being indicative of the presence…” (claims 1-4, 12 and 14-15), “being indicative of the rotational frequency appropriate” (claim 14), “signal indicative of…” (recited twice at claim 15). It is suggested that Applicant amend in order to recite “generating an output signal indicative of the presence…” and “signal indicative of rotational frequency”, in order to omit improper use of the present participle “being”.
Regarding claim 1, it is similarly the case (for the same reasons as above) that it is suggested that Applicant amend “applying an exciting energy for causing luminescence” in order to instead recite “applying an excitation energy, thereby causing the marker to luminesce” in order to improve clarity/grammar of the recited language.
Claim 1 recites “applying a magnetic field…for magnetic adhesion of the protein coated magnetic microparticles to a working electrode of the measurement cell”. This limitation describes an intended use of the magnetic field and also suggests that the measurement cell was previously described as having an electrode as part of it. It is suggested that Applicant amend, starting at the limitation previous to “applying a magnetic field” in order to recite something such as the following:
“… to a measurement cell, wherein the measurement cell comprises a working electrode,
adhering the protein coated magnetic microparticles to the working electrode of the measurement cell by applying a magnetic field to the measurement cell.”.
Regarding claim 1, it is similarly the case (for the same reasons as above) that it is suggested that Applicant amend “applying an exciting energy for causing luminescence” in order to instead recite “applying an excitation energy, thereby causing the marker to luminesce” in order to improve clarity of the language.
Appropriate correction is required.
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.
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 1-19 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.
Claim 1, line 21 recites "measuring of the luminescence for acquisition of a
measurement signal, and generating an output signal being indicative of the presence of the
analyte in the liquid sample using the measurement signal"; the claim limitation is indefinite because the metes and bound are not clear. It is not readily clear whether Applicant intends that a practitioner performing the method obtains a measurement signal which is itself the luminescent signal obtained from the marker, or rather (and contrary to the first interpretation) if Applicant intends the limitation to read as measuring the luminescence, and using the measured luminescence as some input to further acquire a value referred to as a "measurement signal" (the "measurement signal" being a different variable than the originally measured luminescence), wherein the variable is then further used in order to generate a different "output signal" to indicate presence. It appears that perhaps Applicant intends the limitation as indicating one is acquiring a measurement signal by measuring the luminescence of the marker (i.e., that the measurement of the luminescence represents the "measurement signal"), and further generating an output signal that indicates the presence or absence of the analyte in the liquid sample. However, clarification is needed.
Claim 1 recites “wherein the rotational frequency of the stirring unit is maximally high but below a frequency that causes foaming”, the recited language is indefinite because there is no standard of measure to determine what is or is not encompassed by “maximally high” (i.e., what value/rotational frequency is and is not considered to be encompassed by the language “maximally high”, for example, maximally high relative to an amount of fluid is not the same as maximally high relative to the ability of the stirring unit or a highest possible rotational frequency afforded by a particular equipment). Furthermore, there is no indication what would be considered a frequency that “causes foaming”, and as such it is not clear what rotation frequency the claims are limited to with regards to these limitations as there is no way to clearly determine the boundaries of the claimed subject matter relative to the claimed rotational frequency.
Claim 1 recites the limitation "the previously determined rotational frequency" in lines 8-9. There is insufficient antecedent basis for this limitation in the claim. The claim does, prior to lines 8-9, recite “determining a rotational frequency”, it is suggested that Applicant merely recite “the determined rotational frequency” such that it is clear that Applicant’s claim is in reference to the determining step of the present claimed method (performed just prior to the “stirring” step), and not in reference to some other previously determined rotational frequency. Put another way, it is suggested applicant merely omit the word “previously” to overcome the rejection and to improve clarity of the claimed language.
Claim 2 recites, "wherein extracting a portion of fluid from the receptacle employs a
pipetting probe, and wherein acquiring a signal being indicative of the amount of fluid contained in the receptacle is conducted using the pipetting probe". The claim language is indefinite because it is not readily clear what structure is responsible for "acquiring a signal…using the pipetting probe”. Conventionally, when considering "pipetting probe" under broadest reasonable interpretation, one envisions a device for taking up and dispensing fluid/liquid sample and reagent. It is not readily clear how a "pipetting probe" is used in order to acquire a signal as claimed. The specification fails to redefine "pipetting probe", but rather indicates the pipetting probe may comprise further structure capable of performing the function. See page 8 of the specification, a structure capable of acquiring signal indicative of fluid amount is a capacitive sensor (for example, see claim 3) which can be comprised as part of a pipetting probe (not a pipetting probe itself, which under broadest reasonable interpretation may not include such a sensor). It is suggested that Applicant amend accordingly in order to eliminate any ambiguity regarding the structure which performs the function.
Claim 4 recites "providing a first signal indicative of the amount of fluid contained in the receptacle to a data processing unit, in response to providing the first signal to the
data processing unit receiving a second signal being indicative of the rotational frequency
appropriate for the amount of fluid from the data processing unit". The claim language is indefinite as it is not readily clear whether “a first signal” is referring to the signal acquired at claim 1, or rather “a first signal” is in reference to another different “first signal”. Claim 1 does not refer to the acquired signal as “a first signal”.
Claim 4 recites the limitation "the rotational frequency appropriate for the amount of fluid"; however, the claims fail to previously set forth "a rotational frequency appropriate " as described. Rather the claims previously recite "the rotational frequency" that is "proportional" to the amount of fluid. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites “carrying out a reaction sequence” and “carrying out a detection cycle in a measuring cell”, the claim language “a reaction sequence” and “a detection cycle” are indefinite claim language because claim 10 depends from claim 8, and further claim 1, and claim 1 recite the language that the method is “detecting an analyte in a liquid sample using a series of analysis cycles”. The language “reaction sequence” and “detection cycle” are not consistent with the prior used language “analysis cycle”, and as a result it is not clear if “reaction cycle” and “a detection cycle” are part of the previously claimed “series of analysis cycles”, or rather if “a detection cycle” refers to a distinct event that is merely part of the further steps recited at claim 8. Applicant should amend the claim to clarify whether or not the “reaction sequence” and “detection cycle” are part of a single cycle of the “series of analysis cycles”, (i.e., wherein one cycle of the series of analysis cycles comprises carrying out a reaction sequence and a detection cycle…).
Further related to the rejection immediately above, claim 10 recites the language “further comprising” suggesting that the limitations of claim 8 are further performed in addition to those steps recited at claim 1, and not specifically providing additional detail further limiting those steps of claim 1 (because the steps recited at claim 10 are not clearly tied to, or referenced back to, those steps of mixing, incubating, transporting, etc., of independent claim 1. The claim language at 10 is indefinite because it is not clear from the recited language whether the “carrying out a reaction sequence” recited at claim 10 is a further subsequent combination of events performed in addition to those recited at claim 1, or rather if these limitations are further limiting the steps at claim 1 from mixing through generating signal. It appears Applicant’s intention is that the method of claim 1 comprises carrying out a reaction sequence (referring to the prior claimed mixing through transporting steps) and a detection cycle (the steps of claim 1 performed after the transporting step of claim 1), i.e., that the limitations of claim 10 are further limiting/providing details specific to those steps of claim 1. For the purposes of prior art, the claims are interpreted in this way and Applicant should clarify in their response.
Claim 10 also recites “which the complex is contacted with a working electrode in such a manner that said microparticle is attracted by the magnetic field of a magnetic component positioned on the side of the working electrode facing away from the sample”, the language “in such a manner” implies a particular type of way the contacting is performed. It is unclear from the recited language if this is intended as the method comprising a magnet positioned on the side of the electrode to attract the complex to the working electrode, or if this language is referring to a manner of contacting that is performed that allows attraction of the complex by the magnet. The recited language is confusing because claim 1 already recites “applying a magnetic field to the measurement cell for magnetic adhesion of the protein coated magnetic microparticles to a working electrode”, so it appears that rather than being “contacted in such a manner”, it is actually the magnetic field which facilitates the contacting action.
Claim 11 recites “sampling an output signal of the optical sensor; claim 1 previously recites “an output signal”. The language is indefinite because it is not clear if the language at 11 is one and the same as the output signal of claim 1, or if the limitation is referring to other possible output signal by referring to it as “an output signal” instead of “the output signal”.
Regarding claims 4, 5 and 12, the claims recite “data processing unit”, see as discussed in detail previously above (under claim interpretation) the originally filed specification fails to disclose a corresponding structure, material or act for performing the entire claimed function and to clearly link the structure, material or act to the function. See as discussed in detail above (under 35 U.S.C. 112(f)), the data processing unit is described as performing various functions, however, there is not adequate structure described in the specification to perform these claimed functions. In particular, the cited paragraphs of the originally filed specification merely state that the data processing unit is the structure that achieves the claimed functions, but fails to indicate a particular structure (other than that in comprises a table). The indication that the structure comprises a table, alone is insufficient structure for performing the entirety of the functions as claimed.
The specification does indicate the action of controlling the stirring unit to stir the fluid is performed by a structure referred to as the "control unit 132" (e.g., para [0056], other functional limitations for control unit described at para [0052]), however, the specification fails to clearly communicate the "data processing unit" as being one and the same as the "control unit", or communicate the "control unit" as a part/structure of the "data processing unit". Furthermore, "control unit' itself is a nonce term that lacks any particular structure/structural component(s).
See as indicated in detail above (under Priority), the effective filing date of the claimed invention is 04/14/2023 (the claimed language “maximally high” is broader in scope, and as such unsupported by the earlier filed applications), and as a result, Applicant’s own work, US 10,422,797, qualifies as prior art.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 10,422,797.
‘797 similarly teaches an electrochemiluminescence method of detecting an analyte in a liquid sample (see ‘797, claim 1), the method comprising, for an analysis cycle comprising providing a receptacle containing a fluid comprising protein coated magnetic microparticles to a stirring unit (‘797, claim 1), acquiring a signal being indicative of an amount of the fluid contained in the receptacle (‘797, claim 1), determining a rotational frequency for the stirring unit dependent on the amount of fluid in the receptacle (‘797, claim 1), the rotational frequency being proportional to the amount of fluid, stirring the fluid for a predefined period of time by applying the previously determined rotational frequency (‘797, claim 1, “for a period of time at the determined rotational frequency”), , extracting a portion of the fluid comprising the protein coated magnetic microparticles from the receptacle (‘797, claim 1, “taking a portion”), thereby reducing the amount of the fluid contained in the receptacle, mixing a portion of the liquid sample with the portion of the fluid comprising the protein coated magnetic microparticles and with a marker (‘797, claim 1), incubating the mixture comprising the analyte, the protein coated magnetic microparticles, and the marker in an incubator (‘797, claim 1), transporting a portion of the mixture from the incubator to a measurement cell (‘797, claim 1), applying a magnetic field to the measurement cell for magnetic adhesion of the protein coated magnetic microparticles to a working electrode of the measurement cell (“797, claim 1, see at the “carrying out a detection cycle” step), applying an excitation energy for causing luminescence (‘797, claims 1, 10 and 11), measuring of the luminescence for acquisition of a measurement signal (‘797, claims 1, 10, 11), and generating an output signal being indicative of the presence of the analyte in the liquid sample using the measurement signal (claim ‘797, claim 1).
The method of ‘797 consistent with the present claim 1 teaches the method performed/using a series of analysis cycles (see at ‘797 claim 7), teaching the predefined (determined) period of time is held constant for each stirring process (at each cycle, see ‘797 at claim 7).
‘797 does teach the stirring is performed for the purpose of homogenization and disaggregation of the microparticles (see for example, at the abstract and also col. 4, lines 15-30).
And although ‘797 does teach the applied rotational frequency should be high enough to provide for short time periods for stirring the fluid, but not too high to cause foam formation, does anticipate “maximally high” in terms of a frequency that is maximally high enough that it prevents microparticles from depositing on the bottom of the receptacle while also not forming foam (see 797 does disclose rotational frequency “should be high enough to provide for short time periods” and is recited as a variable that is performed to achieve the result of preventing microparticles from depositing at the bottom of the receptacle (abstract), as a result, the rotational frequency is considered to be a result effective variable, i.e., a variable which achieves a recognized result (in this case, a speed which achieves homogenization disaggregation, without foaming).
Although ‘797 does anticipate the claim because the specification does support “maximally high” in this context (discussed immediately above), the claimed language “maximally high” as recited in the present claim is broader in scope than merely referring to high enough to prevent deposition of microparticles in the bottom of the receptacle (as is supported by earlier priority documents) yet low while preventing foam formation (and as a result is considered new matter relative to the earlier filed applications, see discussed above under Priority, which is why the claims were not afforded the earlier date).
Regarding claims 2-3 and 14, see ‘797 at claims 1, 2, and 14 (extracting employs a pipetting probe, employs capacitive method for acquiring signal indicative of amount of fluid in receptacle).
Regarding claims 4, 5 and 15, see ‘797 at claims 1, 4 and 5 (providing a first signal indicative of amount of fluid to a data processing unit, receiving a second signal indicative of rotational frequency for that amount, the frequency looked up in a stored database table).
Regarding claim 6, data comprised in the table is determined empirically (see ‘797 at claim 6).
Regarding claims 7 and 16, see ‘797 at claim 8, stirring conducted prior to extraction from receptacle.
Regarding claims 8 and 17, see ‘797, at claim 10, excitation energy is applied by applying electrical energy, radiation energy and/or chemical energy.
Regarding claims 9 and 18, see ‘797, at claim 11 marker capable of effecting electrochemiluminescence, electronically active substance contributes to the reaction resulting in luminescence.
Regarding claim 10, see ‘797 at claim 12, ‘797 reciting the same reaction sequence and detection cycle to be carried out as presently claimed.
Regarding claims 11 and 19, see ‘797, at claim 13, reciting measurement signal acquired by sampling an output signal of the optical sensor.
Regarding claim 12, see further ‘797 at col. 3, lines 20-45, ‘797 recites a system comprising the same structure as that presently claimed (comprising structures, the structures that perform the recited functions, that read on the claimed a stirring unit, measuring unit, extraction component, incubator, trigger component, acquisition component and data processing unit as presently claimed), see further col. 5, lines 55-67, col. 6, lines 10-28, lines 45 to col 7, line 7, and Figure 1, described also col. 7, lines 15-43).
Regarding the limitations at the end of present claim 12, namely wherein the stirring is performed for homogenization and disaggregation of the microparticles, wherein the rotational frequency of the stirring unit is maximally high but below a frequency that causes foaming it is also the case that the limitations specific to the reason the stirring is performed (for homogenization and disaggregation) and for how the stirring is performed (wherein the rotational frequence… is maximally high but below a frequency that causes foaming) are also directed to the use of the claimed system and not the structure of the system itself. Regardless, see as cited above, ‘797 recites frequency that reads on that which is claimed, capable of the same intended functions (prevent aggregation and for homogenization, creates a dispersion of the microparticles in the receptacle).
Regarding claim 13, see further ‘797 at the end of col. 13, lines 54 to col. 14, ‘797 teaches storing the frequencies for the fluid amounts in a database in a table, such that the system is able to access the database and look up the appropriate rotation frequency from the table.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 12 and 13 rejected over U.S. Patent No. 11,703,504 (previously 16/561,284)
Claims 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,703,504.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
‘504 similarly recites an electrochemiluminescence analysis system for detecting an analyte in a liquid sample, the system comprising: a stirring unit for stirring a fluid comprising protein coated magnetic microparticles provided in a receptacle (see ‘504 claim 1), a measuring unit being operable to generate a signal indicative of an amount of fluid in the receptacle (‘504, claim 1), an extraction component for extracting a portion of the fluid comprising the protein coated magnetic microparticles from the receptacle (‘504, claims 4-6), an incubator for receiving a liquid comprising the analyte, the portion of magnetic microparticles and a marker for marking the analyte, the marker being capable of effecting luminescence upon application of excitation energy (‘504, claim 1), a trigger component for applying the excitation energy for causing the luminescence, an acquisition component for measuring the luminescence the acquisition component being operable to provide a measurement signal (‘504, claim 1), a data processing unit (see also this limitation addressed previously above, under 35 U.S.C. 112(b)) being adapted to: determine a rotational frequency for the stirring unit using the signal indicative of the amount of fluid in the receptacle, the rotational frequency being proportional to the amount of fluid, control the stirring unit to stir the fluid for a predefined period of time by applying the previously determined rotational frequency, the predefined period of time being held constant for each stirring process, and generate an output signal indicative of presence of analyte in the liquid sample (see ‘504 recites a system comprising structure (e.g., control unit) that performs the same functions, claims 1.
Regarding the limitations at the preamble of present claim 12, namely “for detecting…using a series of analyses cycles”, the claimed limitation “using a series of analyses cycles is directed to the intended use of the claimed electrochemiluminescence analysis system. The normal purpose of a claim preamble is to recite the purpose or intended use of the claimed invention. Such statements merely define the context in which the invention operates and usually will not limit the scope of the claim (MPEP 2111.02 and DeGeorge v. Bernier, Fed. Cir. 1985, 226 USPQ 758, 761 n.3).
In the instant case, the statements in the preamble do not provide antecedent basis for terms in the body of the claim, and are not essential to understand the limitations or terms in the body of the claim. The claims do not include, for example, active method steps directed to using a series of analyses cycles (the claim is directed to a product, not a method comprising active steps). In the present case, the intended use, as recited at the preamble does not impart any particular additional structural feature or limitation to the claimed product itself.
Regarding the limitations at the end of present claim 12, namely wherein the stirring is performed for homogenization and disaggregation of the microparticles, wherein the rotational frequency of the stirring unit is maximally high but below a frequency that causes foaming it is also the case that the limitations specific to the reason the stirring is performed (for homogenization and disaggregation) and for how the stirring is performed (wherein the rotational frequence… is maximally high but below a frequency that causes foaming) are also directed to the use of the claimed system and not the structure of the system itself. Based on the claims of ‘504, it appears that the analysis system as claimed similarly recites sufficient structure for performing functions consistent with as claimed, see because ‘504 is reciting a structure (control unit) that manipulates/controls both duration and frequency of stirring, see ‘504 for example at claims 1 and 8. Based on the limitations of ‘504, the present claimed system of independent claim 12 is not structurally distinct from the system of ‘504.
Claims 13 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,703,504 in view of Washburn et al., US PG Pub No. 2003/0068825A1 in view of Friggens et al., US PG Pub No. 2004/0098207A1.
Regarding claim 13, see ‘504 at claim 2 (the system of ‘504 recites a stored database comprising).
‘504 is substantially similar to the claimed system, however, ‘504 does not explicitly use the language “table” in reference to the information stored in their database.
Washburn et al. is another example of an analysis system, the system comprising stored information that is stored as a database, see for example para [0142] of Washburn, regarding information stored in a database, information is stored in tables or arrays within the database to facilitate cataloging, sorting querying and storage/retrieval of the information.
See also Friggens et al., at para [0090], which refers to storing information/data in a table in a database, describing aggregation of data stored in a table in a database as a convenient arrangement (“aggregation of data may conveniently be arranged or stored in a table in the database”).
It would have been further prima facie obvious to one having ordinary skill in the art that the information stored in the database of ‘504 (information relating rotation frequency to fluid volume/amount) be stored in the format of a table, as in either or both of Washburn et al. and Friggens et al. as an obvious matter of applying a known technique for storing data in a database, one motivated to do so to facilitate storage/retrieval of that necessary stored information in a convenience and accessible way (see consistent with Washburn and Friggens cited above). One having ordinary skill in the art would have a reasonable expectation of success because the claims of ‘504 do not limit the storage of the information in the database to any particular format, and as such one would expect success storing the information in the format of a table given this is an art recognized technique for storing data/information.
Claims 1-11 and 14-19 rejected over U.S. Patent No. 10,422,797 (previously 14/968,118)
Claims 1-11 and 14-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,422,797 in view of Degan P, Podestà A, Montagnoli G. Time-resolved fluoroimmunoassay. Mol Biotechnol. 1999 Dec 15;13(3):215-22. (doi: 10.1385/MB:13:3:215. PMID: 10934534) and Wang et al., CN1074224-A (English machine translation obtained via PE2E search, see attached).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
‘797 similarly recites an electrochemiluminescence method of detecting an analyte in a liquid sample (see ‘797, claim 1), the method comprising, for an analysis cycle comprising providing a receptacle containing a fluid comprising protein coated magnetic microparticles to a stirring unit (‘797, claim 1), acquiring a signal being indicative of an amount of the fluid contained in the receptacle (‘797, claim 1), determining a rotational frequency for the stirring unit dependent on the amount of fluid in the receptacle (‘797, claim 1), the rotational frequency being proportional to the amount of fluid, stirring the fluid for a predefined period of time by applying the previously determined rotational frequency (‘797, claim 1, “for a period of time at the determined rotational frequency”), extracting a portion of the fluid comprising the protein coated magnetic microparticles from the receptacle (‘797, claim 1, “taking a portion”), thereby reducing the amount of the fluid contained in the receptacle, mixing a portion of the liquid sample with the portion of the fluid comprising the protein coated magnetic microparticles and with a marker (‘797, claim 1), incubating the mixture comprising the analyte, the protein coated magnetic microparticles, and the marker in an incubator (‘797, claim 1), transporting a portion of the mixture from the incubator to a measurement cell (‘797, claim 1), applying a magnetic field to the measurement cell for magnetic adhesion of the protein coated magnetic microparticles to a working electrode of the measurement cell (“797, claim 1, see at the “carrying out a detection cycle” step), applying an excitation energy for causing luminescence (‘797, claims 1, 10 and 11), measuring of the luminescence for acquisition of a measurement signal (‘797, claims 1, 10, 11), and generating an output signal being indicative of the presence of the analyte in the liquid sample using the measurement signal (claim ‘797, claim 1).
The method of ‘797 consistent with the present claim 1 recites the method performed/using a series of analysis cycles (see at ‘797 claim 7), teaching the predefined (determined) period of time is held constant for each stirring process (at each cycle, see ‘797 at claim 7).
‘797 differs from the present claims in that it fails to recite that the stirring is performed for the purpose of homogenization and disaggregation of the microparticles, and further fails to teach wherein the rotational frequency of the stirring unit is maximally high but below a frequency that causes foaming.
Nonetheless, foam formation was generally recognized in the prior art as a negative factor, see for example Degan preparing an immunoassay reagent (namely antibody), at page 217, step 14, Degan teach that foam formation is to be avoided during protein solubilization steps because it may lead to protein loss or denaturation.
See also as another example, Wang et al., uniformly mixing a microsphere reagent, Wang instruct at mixing steps to avoid foam (page 5 of attached translation).
As cited above, ‘797 is reciting a method comprising setting a stirring rotational frequency and duration to stir microparticles (capable of setting the time and speed), it would have been further prima facie obvious to one having ordinary skill in the art to have provided a stirring speed that achieves mixing (the desired result), but at a speed (under conditions) that avoid foam formation, one motivated to avoid foam formation because it was recognized in the prior art that formation of foam can lead to loss of protein or denaturation (Degan), the prior art supporting that those having ordinary skill recognized that during mixing/solubilizing steps, it was desirable to achieving mix/stirring without formation of foam (Wang).
Further, based on the combined prior art, stirring speed is a result effective variable, i.e., a variable that achieves a recognized result: in the present case, stirring speed is recognized as achieving a mixed solution of the microparticles (maintaining a stirred fluid containing the particles in the receptacle, see ‘797, the method comprising setting a rotational frequency appropriate for the amount of fluid in the receptacle, fluid containing the microparticles), the prior art further recognizing mixing/stirring can result in foam formation, which the art indicates should be avoided. As a result, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the stirring of ‘797, in order to set a rotational frequency sufficient to achieve stir but at a frequency below that which causes foam formation, one motivated to do so in order to avoid protein loss or denaturation (negative effects presented by foam formation as recognized by the prior art), while achieving the desired stirring effect.
One having ordinary skill would have had a reasonable expectation of success given that ‘797 is teaching a method comprising the ability to determine and set a rotation frequency for stirring, as such one would expect the ability to set an optimized frequency.
Regarding claims 2-3 and 14, see ‘797 at claims 1, 2, and 14 (extracting employs a pipetting probe, employs capacitive method for acquiring signal indicative of amount of fluid in receptacle).
Regarding claims 4, 5 and 15, see ‘797 at claims 1, 4 and 5 (providing a first signal indicative of amount of fluid to a data processing unit, receiving a second signal indicative of rotational frequency for that amount, the frequency looked up in a stored database table).
Regarding claim 6, data comprised in the table is determined empirically (see ‘797 at claim 6).
Regarding claims 7 and 16, see ‘797 at claim 8, stirring conducted prior to extraction from receptacle.
Regarding claims 8 and 17, see ‘797, at claim 10, excitation energy is applied by applying electrical energy, radiation energy and/or chemical energy.
Regarding claims 9 and 18, see ‘797, at claim 11 marker capable of effecting electrochemiluminescence, electronically active substance contributes to the reaction resulting in luminescence.
Regarding claim 10, see ‘797 at claim 12, ‘797 reciting the same reaction sequence and detection cycle to be carried out as presently claimed.
Regarding claims 11 and 19, see ‘797, at claim 13, reciting measurement signal acquired by sampling an output signal of the optical sensor.
Correspondence
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/ELLEN J MARCSISIN/ Primary Examiner, Art Unit 1677