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.
Status of the Claims
Claim 1-19 are pending; claims 1-5, 10 and 12-15 are amended; no claims are withdrawn; and no claims are canceled. Claims 1-19 are examined below.
Withdrawn Objections/Rejections
The previous objections to the claims are withdrawn in response to Applicant’s amendments to the claims.
The previous rejections of claims 1-10 and 12-19 under 35 U.S.C. 112(b) are withdrawn in response to Applicant’s amendments to the claims.
The previous rejection of claims under 35 U.S.C. 102(a)(1) is withdrawn in response to Applicant’s amendments to the claims. As amended, the claims receive the benefit of the earlier filing date.
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: “a control unit including an electronic processor…” the control unit able to receive “the signal indicative of the amount of fluid contained in the receptacle” and “receiving a second signal indicative of the rotational frequency proportional to the amount of fluid from the control unit” in claim 4; and
At claim 5, “control unit comprises the table”, the control unit “in response to receiving the signal looks up the table for the rotational frequency proportional to the amount of fluid the signal is indicative of and provides the second signal indicative of the rotational frequency proportional to the amount of fluid”.
Based on the originally filed specification (referring to paras [0056]-[0058]), it is understood that “control unit” is referring to structure that is a computer, see at the specification, the structure comprising an electronic memory, an electronic processor and an interface.
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 § 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 11-19 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.
Claims 1 and 12 reach recite “thereby resulting in the predetermined period of time being a short time period for stirring the fluid”, the language “short time period” is indefinite because it is not readily clear what is and is not considered to be a “short time period for stirring the fluid”. In particular, there is no standard of measure regarding the terminology “short” such that time periods considered to be “short” can be distinguished from those that are not.
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”.
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 and 13 are 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 and Friggens et al., US PG Pub No. 2004/0098207A1.
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 control unit including an electronic processor 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 frequency of the stirring unit is just 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.
‘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 (provided by a table comprising information on which rotational frequency to use for which amount of fluid). Further fails to teach the table stored in a database (claim 13).
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 causing luminescence of the marker (‘797, claims 1, 10 and 11), measuring of the luminescence (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).
See ‘797 at claims 1, 4 and 5 (providing a first signal indicative of amount of fluid to a processing unit, receiving a second signal indicative of rotational frequency for that amount, the frequency looked up in a stored database table). the data comprised in the table is determined empirically (see ‘797 at claim 6).
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 processing unit, i.e., electronic processor), 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.
Response to Arguments
Applicant's arguments filed 04/13/2026 have been fully considered but they are not persuasive for the reasons as indicated in detail below.
Regarding remarks at page 9, the previous objections to the claims are withdrawn in response to Applicant’s amendments to the claims.
Regarding remarks at pages 10-12, see above, the previous rejections of claims 1-10 and 12-19 under 35 U.S.C. 112(b) are withdrawn in response to Applicant’s amendments to the claims. However, see new grounds set forth in response to Applicant’s amendments to the claims.
Regarding remarks at page 12, the previous rejection of claims under 35 U.S.C. 102(a)(1) is withdrawn in response to Applicant’s amendments to the claims. As amended, the claims receive the benefit of the earlier filing date.
At remarks pages 12 Applicant request the rejections on the ground of non-statutory double patenting be held in abeyance. The rejections are as set forth in detail above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN J MARCSISIN whose telephone number is (571)272-6001. The examiner can normally be reached M-F 8:00am-4:30pm.
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/ELLEN J MARCSISIN/Primary Examiner, Art Unit 1677
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