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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/08/26 has been entered.
Claim Interpretation
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: chemical/physical means for limiting evaporation in claim 12.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-4, 6-8, 10-12, 15, 22, and 24 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.
Regarding claim 1, the claim recites the MFP is at least 3 microns without establishing an upper limit. The metes and bounds of the claim limitation is not clear as “at least 3 microns” can includes 3 feet, etc.
Claims 3-4, 6-8, 10-12, 15, 22, and 24 are also rejected for failing to cure the deficiency of claim 1.
Claim Rejections - 35 USC § 103
Claim(s) 1, 3, 4, 7-8, 10-12, 15, 22, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chandler (US 6271046 B1) in view of Mao (US 20140018701 A1).
Regarding claim 1 and 24, Chandler discloses a device for collecting, preserving, and storing a sample of biological fluid (Fig. 1-2), comprising a porous nonwoven medium (sample application matrix 18, Fig. 4), and wherein the medium is sandwiched (a sample application matrix disposed between the front panel and the rear panel; Abstract) between two supports (a housing having a front panel and a rear panel; Col. 3, lines 20-21; abstract; rear panel cover 23, Fig. 2, front panel cover 10, Fig. 1), the two supports being perforated (and also comprises a plurality of windows) opposite one another to allow the medium to appear (testing window 25, solvent application apertures 27 and 29; Fig. 2, col. 7, lines 23-34; first sample application apertures 14, Fig. 1, Col. 7, lines 17-19), wherein the medium comprise semisynthetic fibers and/or synthetic fibers (The selection of a material for the sample application matrix is, to some degree, dependent upon the type of sample to be applied. Generally speaking, however, an open-celled, chemically inert matrix (e.g., porous plastic, filter paper, glass fiber) is preferred. Col. 3, lines 45-50).
Chandler does not specify the MFP of at least 3 microns and a thickness between 100 microns and 2500 microns.
In an analogous art, Mao (Paragraph [0014], figure 3-4) discloses a device (Nib) for collecting, preserving and storing a sample of biological fluid comprising, the device comprising a nonwoven porous medium (para. [0064]) for collecting and maintaining the membrane integrity of the eukaryotic cells contained in the sample, and their constituents (para. [0077]), the medium comprising at least 80% by weight of artificial components of a total weight of the medium (In one embodiment, a plastic nib is made from about 30% PP and about 70% PE (wt:wt %). In other embodiments when PP and PE are combined, PP may be present in a range of from about 100% to about 0% and PE may be present in a range of from about 0 to about 100% (100% to 0%:0% to 100% wt:wt %). When PE is combined with other polymers, the PE is present in at least about 50% (wt %). Para. [0040]); and having a mean flow pore size (MFP) of at least 3 µm (The nibs have a pore size of from about 1 μm to about 200 μm, from about 10 μm to about 100 μm, or from about 20 μm to about 60 μm, para. [0050]), and a thickness of 100-2500 μm (A device with a pen shape contains a 2 mm wide, para. [0173]).
As Chandler discloses one of ordinary skill in the art would have flexibility in selecting chemically inert matrix with preference to glass fiber and porous plastics. Col. 3, lines 45-50), it would have been obvious to one of ordinary skill in the art before the effective filing date to have incorporate the materials of Mao as the material of the sample application matrix to the device of Chandler to derive the claimed invention. Furthermore, one of ordinary skill in the art would have selected the claimed ranges for pore size (The selection of particular pore size dictates flow rate. Col. 4, lines 8-9) and thickness of the material based on the desired flow rate and presence of other elements in the device (Chandler, Whether or not to include such optional elements depends, for example, on the relative thicknesses of the sample application matrix (18) and the stock from which the housing is produced; col. 8, lines 59-63).
Regarding claim 3, Modified Chandler discloses the claimed invention as discussed above in claim 1. Mao discloses the artificial component comprises synthetic fibers chosen from PET (para. [0064]).
Regarding claim 4, Modified Chandler discloses the claimed invention as discussed above in claim 1. Mao discloses the medium comprises a binder (PP) which overlaps with the claimed range (PP may be present in a range of from about 100% to about 0%) (para. [0040]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness. See MPEP § 2144.05.I.
Regarding claim 7, Modified Chandler discloses the claimed invention as discussed above in claim 1. Neither Mao nor Chandler explicitly discloses the semi-synthetic fibers and/or synthetic fibers have a moisture regain value of less than 5% measured by the ASTM D269-15 (2015) standard (implying the materials are hydrophobic). Mao discloses the porous material may be hydrophobic and is chosen depending on the sample to be contacted with the material (para. [0068]) as hydrophobic material may be used to collect non-aqueous based, low surface tension liquid samples (para. [0050]).
As the hydrophobicities are variables that can be modified, among others, by adjusting the moisture regain value of the material, with hydrophobicity both increasing as the moisture regain value is decreased, the precise moisture regain value with water would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed moisture regain value cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the moisture regain value in the Mao to obtain the desired balance between hydrophobicity as taught by Mao (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Regarding claim 8, Modified Chandler discloses the claimed invention as discussed above in claim 1. Neither Mao nor Chandler explicitly discloses the semi-synthetic fibers and/or synthetic fibers have a contact angle with water of less than 75% (implying the fibers are hydrophilic). Mao discloses the porous material may be treated to increase the hydrophilicity of the porous nibs (para. [0009]), doing so allows the liquid to be wicked into the porous component through capillary force ([para. [0011]).
As the hydrophilicity are variables that can be modified, among others, by adjusting the contact angle of the material, with hydrophilicity both increasing as the contact angle is decreased, the precise contact angle with water would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed contact angle with water cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the contact angle in the Mao to obtain the desired balance between hydrophilicity as taught by Mao (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Regarding claim 10, Modified Chandler discloses the claimed invention as discussed above in claim 1. Mao discloses the medium is exclusively semi-synthetic and/or synthetic fibers (In one embodiment, a plastic nib is made from about 30% PP and about 70% PE (wt:wt %). In other embodiments when PP and PE are combined, PP may be present in a range of from about 100% to about 0% and PE may be present in a range of from about 0 to about 100% (100% to 0%:0% to 100% wt:wt %). When PE is combined with other polymers, the PE is present in at least about 50% (wt %). Para. [0040]).
Regarding claim 12, Modified Chandler discloses the claimed invention as discussed above in claim 1. Mao discloses the material further comprises at least one physical and/or chemical means capable of limiting the evaporation of the biological sample (After retracting the nib into the device, the opening of the device which transmitted the nib may be capped, thereby preventing evaporation of sample contained in the nib or contamination of the sample in the nib. Para. [0128]).
Regarding claim 22, Modified Chandler discloses the claimed invention as discussed above in claim 1. Mao and Chandler disclose the device is in the form of a card (Mao, In general, the nib shapes may be any appropriate shape that allows the nib to performed the desired functions described herein. For example, the nib may be provided as…a square shape, para. [0036]; Chandler, the sample application matrix is a flat square surface).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mao in view of Rous (The preservation of living red blood cells in vitro: I. Methods of preservation, 1916) as cited in previous OA.
Regarding claim 11, Mao discloses the claimed invention as discussed above in claim 1. Mao does not explicitly disclose the medium is impregnated with an isotonic preservative. Mao discloses the medium may be treated with functional additives useful in preserving an analyte (para. [0008]).
In an analogous art, Rous discloses a technique of preserving blood cells with preservative isotonic solution (Abstract). It would have been obvious to one of ordinary skill in the art before the effective filing date to have further modify the medium of Mao by treating with isotonic preservative. Doing so allows for preservation of blood cell sample (Rous, Abstract).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chandler in view of Mao as discussed above in claim 1, and further in view of Ward (US 20140137792 A1) as cited in previous Office Action.
Regarding claim 13, Modified Chandler discloses the claimed invention as discussed above in claim 1. Neither Mao nor Chandler explicitly discloses thickness of the material to be in the claimed range.
In an analogous art, Ward discloses a wick for use in determining sufficiency of an amount of analyte fluid (Abstract) comprising a wicking material comprising an indicator layer (320, Fig. 3-4). The indicator layers are formed from polymer fibers (particularly porous fibers) (para. [0052]). Furthermore, Ward discloses the wicking structure can be tailored to provide desired characteristics by changing the thickness of the structure (It will further be understood that the thickness of the wick structure (or the depth of the indicator layer/material, depending on the embodiment) in the sufficiency indicator portions of the assay wicks of the invention will be dependent on the degree of translucency of the material when wetted by the analyte fluid. Para. [0053]; Any or all of these characteristics can be adjusted to assure that the indicator layer/portion becomes visible only when an amount of analyte fluid sufficient to assure a desired reaction with the reagents of the analyte test section is present. Para. [0054]).
As the wicking capacity and fluid sufficiency are variables that can be modified, among others, by adjusting the thickness, with wicking capacity and fluid sufficiency both increasing as the thickness is increased (generally), the precise thickness would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed thickness cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the thickness in Mao’s material to obtain the desired balance between the fluid sufficiency/wicking capacity and thickness as taught by Ward (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chandler in view of Mao as discussed above in claim 1, and further in view of Donath (AU 2014201346 A1) as cited in previous OA.
Regarding claim 15, Modified Chandler discloses the claimed invention as discussed above in claim 1. Chandler discloses one of the supports is extended laterally by a flap covering at least the area of the support facing the medium (Sample application cover flaps 11 and 13, Fig. 1). Neither Mao nor Chandler discloses the other support is covered with a film impermeable to gases and liquids at least in the region opposite the medium.
In an analogous art, Donath discloses a sampling fluid collection device (Figure 15 and para. [0115]). Donath discloses the need for the need to incorporate a fitted plastic or gasket seal (interpreted as film impermeable to gas or water) to minimize evaporation (para. [0149]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have further modified device of Chandler to incorporate a tight seal to the cap/support structure of Chandler’s device as taught by Donath to derive the claimed invention. Doing so minimize evaporation after sample has been collected (Donath, para. [0149]).
Allowable Subject Matter
Claims 6 and 23 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.
Closest arts, Chandler in view of Mao discloses the claimed invention of claim 1. Neither Chandler nor Mao explicitly discloses the claimed range for the MFP. At best, Mao discloses that flow rate of the sample through the material is dependent on the pore size and does not disclose the need to establishing upper and lower limits for the pore size in light of the thickness of the material.
Response to Arguments
Applicant’s arguments, see Pages 6-9, filed 01/08/26, with respect to the rejection(s) of claim(s) 1, 3, 6, 10, 12, 14, 22, and 23 under 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Chandler.
Conclusion
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/M.H./Examiner, Art Unit 1758 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797