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 .
Election/Restrictions
Applicant’s election without traverse of group III comprising claims 53 – 65 in the reply filed on 10/2/2025 is acknowledged.
Claims 42 – 52 and 66 – 71 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/2/2025.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 53 – 65 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Sureda et al. (WO 2014/183886 A1; hereinafter “Sureda”).
Regarding claim 53, Sureda teaches a cartridge apparatus structure (strip 10; pages 14 – 20; figures 1 – 3) comprising:
(a) a sample inlet port (sample inlet port 12; figure 1a) configured to receive a blood sample;
(b) a mixing compartment (first portion 14a) capable of containing a depleted plasma that is depleted of a coagulation factor (page 19, lines 6 – 14), wherein said mixing compartment is configured to receive at least a portion of said blood sample from said sample inlet port, to form a mixture;
(c) a first reagent compartment (second portion 14b) capable of containing a calcium salt (page 15, lines 1 – 8), wherein said mixing compartment is in fluidic communication with said first reagent compartment and is configured to receive at least a portion of said calcium salt from said first reagent compartment; and
(d) a detection compartment (third portion 14c) configured to receive at least a portion of said mixture from said mixing compartment.
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The cited prior art teaches all of the positively recited structure of the claimed apparatus. If the prior art structure is capable of performing the intended use, then it meets the claim. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. The manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. Apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function (see MPEP §§ 2114 and 2173.05(g)).
Regarding claims 55, 57 – 60, 62, 63 and 65, these claims are considered to be statements of intended use or manner of operation, and are not given patentable weight to the apparatus claim. These claims do not further limit or define the claimed apparatus structure itself. As indicated above, the prior art teaches all of the positively recited structure of the apparatus as claimed. Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim. Furthermore, “[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims.” See In re Young, 75 F.2d *>996<, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115).
Regarding claim 54, Sureda teaches the cartridge of claim 53, further comprising a second reagent compartment capable of containing a coagulation contact phase activator (pages 5 and 6), wherein said mixing compartment is in fluidic communication with said second reagent compartment and is configured to receive at least a portion of said coagulation contact phase activator from said second reagent compartment (The reaction areas of the one or more ingredients or reagents can be kept separate by a physical barrier, such as a wall of compartment, therefore indicating the incorporation of a second reagent compartment; page 7, lines 14 – 20; page 15, line 35 – page 16, line 3).
Regarding claim 55, Sureda teaches the cartridge of claim 54, wherein said first reagent compartment or said second reagent compartment further contains a citrate source, a tissue factor, a phospholipid, or any combination thereof (page 1, lines 12 – 21; page 15, lines 1 – 8).
Regarding claim 56, Sureda teaches the cartridge of claim 54, further comprising a capillary configured to fluidically connect said mixing compartment with said first reagent compartment or said second reagent compartment (e.g., capillary tracks 15a and 15b fluidically connect the separate reagent portions; page 16, lines 11 – 19).
Regarding claim 57, Sureda teaches the cartridge of claim 54, wherein said coagulation contact phase activator comprises a kaolin (page 2, lines 1 – 4).
Regarding claim 58, Sureda teaches the cartridge of claim 54, wherein said coagulation contact phase activator comprises an ellagic acid (page 2, lines 1 – 4).
Regarding claim 59, Sureda teaches the cartridge of claim 53, wherein said depleted plasma is lyophilized (page 16, lines 1 – 3).
Regarding claim 60, Sureda teaches the cartridge of claim 53, wherein said depleted plasma is depleted of at least one of: Factor II, Factor V, Factor VII, Factor VIII, Factor IX, Factor X, Factor XI, and Factor XII (page 2, lines 6 – 10).
Regarding claim 61, Sureda teaches the cartridge of claim 53, further comprising a reference compartment containing a reference sample (the control reaction area 18 may comprise a lyophilized blood or plasma sample of known composition; page 16, lines 34 and 35).
Regarding claim 62, Sureda teaches the cartridge of claim 61, wherein said reference sample is a plasma containing said coagulation factor (page 1, lines 12 – 21).
Regarding claim 63, Sureda teaches the cartridge of claim 59, wherein said reference sample is lyophilized (the control reaction area 18 may comprise a lyophilized blood or plasma sample of known composition; page 16, lines 34 and 35).
Regarding claim 64, Sureda teaches the cartridge of claim 59, wherein said reference compartment is in fluidic communication with said first reagent compartment and is configured to receive at least a portion of said calcium salt (page 15, lines 1 – 8) from said first reagent compartment (e.g., capillary tracks 15a and 15b fluidically connect the separate reagent portions; page 16, lines 11 – 19).
Regarding claim 65, Sureda teaches the cartridge of claim 53, wherein said calcium salt comprises calcium chloride, calcium acetate, calcium carbonate, calcium glubionate, calcium gluconate, calcium hydroxide, calcium nitrate, calcium sulfonate, calcium phosphate, or a mixture thereof (page 15, lines 1 – 8)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Arkel et al. (US 5,766,869) teaches a factor V ratio blood test for susceptibility to thromboembolism.
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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796