Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 cartridge comprising a sample unit configured to… and a plurality of reagent units…configured to (in claim 95, lines 3-8; and claim 129, lines 3-8);
--a sample unit configured to receive the biological sample…. (in claim 95, lines 4-5; and claim 129, lines 4-5);
--a plurality of reagent units…configured to contain a reagent… (in claim 95, lines 6-8; and claim 239, lines 6-8);
--an assay unit comprising a reagent configured to interact with the analyte, wherein the assay unit is configured to run the assay… (in claim 95, lines 9-11; and in claim 97, lines 1-3; and claim 117, line 1; and claim 117, lines 1-3 and claim 129, lines 9-11);
--a reagent configured to interact with the analyte (in claim 95, lines 9-10);
--an assembly comprising a cartridge stage for… … (in claim 95, lines 12-14; and in claim 120, lines 1-2; and claim 129, lines 12-14);
--a cartridge stage for receiving… (claim 95, lines 13-14; and claim 116, lines 4-5; claim 129, lines 13-14; and claim 129, lines 13-14);
--a fluid transfer device…configured to transfer…. (in claim 95, lines 15-17; and claim 116, lines 6-9; and claim 124, lines 1-3; and claim 125, lines 1-3; claim 129, lines 15-17);
--an optical detector configured to detect… (in claim 95, lines 18-19; and claim 116, lines 10-11 and claim 129, lines 18-19);
--an external device…configured to receive the protocol…. (in claim 95, lines 28-29; and in claim 102, lines 1-7; and claim 115, lines 1-2);
--a computer system (in claim 115, line 2; and claim 116, lines 20-24; and claim 118, lines 1-3; and claim 121, lines 1-3; and claim 123, lines 1-2);
--a user station (in claim 116, lines 25-28);
--a communication assembly (in claim 116, line 12);
--a display (in claim 116, line 26);
--a software for controlling… (in claim 116, line 26).
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.
A cartridge comprising a sample unit configured to… and a plurality of reagent units…configured to (in claim 95, lines 3-8; and claim 129, lines 3-8) is interpreted to be encompassing a cartridge as disclosed by Applicant such as in paragraphs 0070, 0072, 0073 [in the application as filed by Applicant], and elsewhere in the specification, and their equivalents.
A sample unit configured to receive the biological sample…. (in claim 95, lines 4-5; and claim 129, lines 4-5) is interpreted to be encompassing a sample unit as disclosed by Applicant such as in paragraphs 0069, 0072 and elsewhere in the specification, and their equivalents.
A plurality of reagent units…configured to contain a reagent… (in claim 95, lines 6-8; and claim 239, lines 6-8) is interpreted to be encompassing a plurality of reagent units as disclosed by Applicant such as in paragraphs 0069-0071 and elsewhere in the specification, and their equivalents.
An assay unit comprising a reagent configured to interact with the analyte, wherein the assay unit is configured to run the assay… (in claim 95, lines 9-11; and in claim 97, lines 1-3; and claim 117, line 1; and claim 117, lines 1-3 and claim 129, lines 9-11) is interpreted to be encompassing an assay unit such as in paragraphs 0069, 0071, 0072 and elsewhere in the specification, and their equivalents.
A reagent configured to interact with the analyte (in claim 95, lines 9-10) is interpreted to be encompassing a reagent such as in paragraph 0071 and elsewhere in the specification, and their equivalents.
An assembly comprising a cartridge stage for… … (in claim 95, lines 12-14; and in claim 120, lines 1-2; and claim 129, lines 12-14) is interpreted to be encompassing an assembly as disclosed by Applicant in paragraph 0109, and elsewhere in the specification, and its equivalents.
A cartridge stage for receiving… (claim 95, lines 13-14; and claim 116, lines 4-5; claim 129, lines 13-14; and claim 129, lines 13-14) is interpreted to be encompassing a cartridge stage as disclosed by Applicant in paragraph 0109, and elsewhere in the specification, and its equivalents.
A fluid transfer device…configured to transfer…. (in claim 95, lines 15-17; and claim 116, lines 6-9; and claim 124, lines 1-3; and claim 125, lines 1-3; claim 129, lines 15-17) is interpreted to be encompassing a fluid transfer device such as disclosed by Applicant in paragraphs 0070, 0072, 0078, 0079, 0080, 0094, and elsewhere in the specification, and its equivalents.
An optical detector configured to detect… (in claim 95, lines 18-19; and claim 116, lines 10-11 and claim 129, lines 18-19) is interpreted to be encompassing an optical detector such as disclosed by Applicant in paragraph 0089, and elsewhere in the specification, and its equivalents.
An external device…configured to receive the protocol…. (in claim 95, lines 28-29; and in claim 102, lines 1-7; and claim 115, lines 1-2) is interpreted to be encompassing an external device disclosed by Applicant such as in paragraphs 0112 and 0126, and elsewhere in the specification, and its equivalents.
A computer system (in claim 115, line 2; and claim 116, lines 20-24; and claim 118, lines 1-3; and claim 121, lines 1-3; and claim 123, lines 1-2) is interpreted to be encompassing a computer system as disclosed by Applicant such as in paragraph 0073, and elsewhere in the specification, and its equivalents.
A user station (in claim 116, lines 25-28) is interpreted to be encompassing a user station as disclosed by Applicant such as in paragraph 0105, and elsewhere in the specification, and its equivalents.
A communication assembly (in claim 116, line 12) is interpreted to be encompassing a communication assembly as disclosed by Applicant such as in paragraph 0126, and elsewhere in the specification, and its equivalents.
A display (in claim 116, line 26) is interpreted to be encompassing a display as disclosed by Applicant such as in paragraphs 0156, 0160 and 0161, and elsewhere in the specification, and their equivalents.
A software for controlling… (in claim 116, line 26) is interpreted to be encompassing a software as disclosed by Applicant such as in paragraph 0112, 0168 and 0169, and elsewhere in the specification, and its equivalents.
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 95, 97, 101-105, 115-118, 120-121 and 123-129 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 103 recites in line 9 “the first concentration”. The claim lacks sufficient antecedent basis for this limitation. For examination purposes, “the first concentration” is interpreted to be referring to the concentration recited in claim 102, line 4.
Claim 116, line 13 recites “the assembly”. However, claim 116 recites an assembly in line 3 and a communication assembly in line 12, and therefore it is not clear as to which assembly is being referred to. For examination purposes, “the assembly” in line 13 is interpreted to be referring to the assembly in line 3.
Claim 95 is not clear as to whether the assembly recited in line 12 comprises the cartridge stage (in lines 13-14), or comprises the cartridge stage as well as the fluid transfer device (in lines 15-17). On one hand, the semicolon in line 14 appears to indicate that the assembly does not comprise the fluid transfer device. However, on the other hand, lines 20-27 appears to indicate that the fluid transfer device is part of the assembly, since “the assembly is configured to operate the cartridge stage and the fluid transfer device according to a protocol…..”. Clarification is required.
Likewise, claim 116 is not clear as to whether the assembly recited in line 3 comprises the cartridge stage (in lines 4-5), or comprises the cartridge stage as well as the fluid transfer device (in lines 6-7). On one hand, the comma in line 5 and the semicolon in line 9, both appear to indicate that the fluid transfer device is part of the assembly. The wherein clause in lines 13-19 also appear to indicate that the fluid transfer device is part of the assembly .On the other hand, the word “and” in line 24 appears to indicate that the fluid transfer device is not part of the assembly, but is recited as an element of the claimed system. Clarification is required.
Likewise, claim 129 is not clear as to whether or not the assembly in line 12 comprises the cartridge, or the cartridge and fluid transfer device. On one hand, the semicolon in line 14 appears to indicate that the assembly does not comprises the fluid transfer device. On the other hand, the wherein clause in lines 20-26 appears to indicate that the assembly comprises the fluid transfer device, since it recites “wherein the assembly is configured to operate the cartridge stage and the fluid transfer device according toa protocol…..” Clarification is required.
The remaining claims are rejected since they depend from one of the claims above, without clarifying the issue above.
Allowable Subject Matter
Claim 95, 116 and 129 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 97, 101-105, 115, 117-118, 120-121, 123-128 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance:
It was not found in the prior art search a teaching or suggestion for a system comprising:
a combination of a cartridge comprising a sample unit configured to receive a sample unit configured to contain a sample unit configured to contain a sample and reagent units configured to contain a reagent;
an assay unit comprising a binding reagent configured to run an assay so as to yield an optical signal in the assay unit;
and an assembly comprising:
a cartridge stage for receiving the cartridge, wherein the cartridge stage is movable relative to the assay unit;
a fluid transfer device coupled to the assay unit and configured to transfer the sample and a reagent from a reagent unit to the assay unit;
and an optical detector configured to detect an optical signal in the assay unit coupled to the fluid transfer device,
wherein the assembly is configured to move the cartridge to a first location to place the sample unit of the cartridge in fluid communication with the assay unit and to a second location to place a reagent unit in fluid communication with the assay unit.
Examiner notes that the previously cited reference, Kumar (US 5,976,896), the closest prior art found, does not disclose or suggest an assembly configured to move a cartridge comprising a sample unit and reagent unit(s), to a first location to place the sample unit of the cartridge in fluid communication with an assay unit and to a second location to place a reagent unit in fluid communication with the assay unit. While Kumar teaches that the sample tray 3 is positioned under the cartridge 1, which holds radially spaced apart antigen coated capillary tubes 2 (col. 21, lines 17-34), there is no teaching in Kumar that the sample tray moves to place one well (such as a sample unit) into communication with a capillary tube (equivalent to the claimed assay unit) and also moves to place another well (such as a reagent unit) into fluid communication with the same capillary. See Figures 1 and 12 of Kumar, which shows that each well is placed under separate capillary tubes (2).
Also, Kumar does not teach an optical detector configured to detect an optical signal in the assay unit [while] coupled to the fluid transfer device.
In column 32, lines 20-46 wherein the sample tray (equivalent to Applicant’s cartridge with sample or reagent units) is moved to the cartridge of capillaries, the detector is not arranged to detect a signal within the assay unit when the assay unit is coupled to the fluid transfer device, since the syringe (210) (equivalent to a fluid transfer device) is provided at a separate location from the detection station (203) (see fig. 13, which shows the interior of fig. 12.)
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Montgomery whose telephone number is (571)272-0894. The examiner can normally be reached Mon-Fri, 9-5:30 PM PST.
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/Ann Montgomery/Primary Examiner, Art Unit 1678
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