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 .
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) 61 – 90 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Plante et al. (US 8,932,539 B2; hereinafter “Plante”).
Regarding claim 61, Plante teaches a device (receiving vessel 1; Abstract; col. 5, lines 11 – 34; figures 1 – 3) for collecting a biological sample of a subject (col. 1, lines 1 – 52), comprising:
a container (receiving vessel 1) comprising a piercer (knife 19) extending across a longitudinal axis of said container towards an opening (entrance aperture 4) of said container; and
a cap (sealing cap 2) comprising a pierceable container (liquid tight reservoir 12 comprising thin-film membrane or foil 13) comprising a reagent for processing or preserving said biological sample (reservoir 12 contains therein a special formula operable to stabilize and preserve biological samples; col. 5, lines 44 – 56),
wherein said device is configured such that upon engagement of said cap with said container to dispose said cap adjacent to said opening, said piercer pierces said pierceable container to release said reagent into said container (col. 5, lines 1 – 66; col. 6, lines 17 – 37; figures 1 – 3).
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Regarding claim 62, Plante teaches the device of claim 61, wherein said piercer (knife 19) pierces said pierceable container (reservoir 12) upon rotation of said cap (cap 2) or said container (vessel 1) (col. 5, lines 11 – 66; col. 6, lines 17 – 37; figures 1 – 3).
Regarding claim 63, Plante teaches the device of claim 61, wherein said engagement of said cap with said container to dispose said cap adjacent to said opening (figure 1; col. 5, lines 49 – 56), and movement of said cap towards said container or movement of said container towards said cap, closes said container (figure 1; col. 5, lines 49 – 56).
Regarding claim 64, Plante teaches the device of claim 61, wherein said cap is configured to be attached to said container at least in part by exerting a pressure on said cap towards said container or exerting a pressure on said container towards said cap, when said cap is adjacent to said opening (col. 6, lines 17 – 37).
Regarding claim 65, Plante teaches the device of claim 61, wherein said cap is configured to be attached to said container at least in part by rotating said cap or said container, when said cap is adjacent to said opening (figure 1; col. 5, lines 49 – 56; col. 6, lines 17 – 37).
Regarding claim 66, Plante teaches the device of claim 61, wherein said attaching of said cap to said container generates a leak-resistant, leak-proof, or airtight compartment (figure 1; col. 6, lines 31 – 37).
Regarding claim 67, Plante teaches the device of claim 61, wherein said cap and said container each comprises threading (thread seat 11 in sealing cap 2 and thread set system 8 in receiving vessel 1; figure 1 col. 5, lines 11 – 66), wherein said threading of said cap and said threading of said container are configured to interface together thereby closing said container (figure 1; col. 5, lines 49 – 56; col. 6, lines 31 – 37).
Regarding claim 68, Plante teaches the device of claim 61, wherein said piercer comprises a rod, wherein a top of said rod comprises a sharp protrusion (piercer comprising knife 19 which is considered a rod comprising a sharp end; figure 1).
Regarding claim 69, Plante teaches the device of claim 61, wherein said pierceable container is configured, such that a pierceable surface of said pierceable container is exposed on a bottom surface of said cap (figure 1 shows the bottom surface of the cap 2 is exposed such that the pierceable portion (knife 19) of the container (vessel 1) is able to pierce the membrane 13 when the cap 2 is closed).
Regarding claim 70, Plante teaches the device of claim 61, wherein said reagent is configured to preserve integrity of analytes in said biological sample, responsive to said releasing of said reagent into said container (col. 5, lines 44 – 46).
Regarding claim 71, Plante teaches the device of claim 70, wherein said analytes comprise nucleic acids, polypeptides, lipids, or carbohydrates (e.g., saliva samples can comprise nucleic acids, polypeptides, lipids and carbohydrates; col. 5, lines 44 – 46). This claim is considered to be a statement of intended use or manner of operation. This claim does not further limit or define the claimed device structure as claimed. The prior art device is considered to be capable of being used in the manner claimed. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The recitation of a new intended use, for an old product, does not make a claim to that old product patentable. The Courts have held that if the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967); and In re Otto, 136 USPQ 458, 459 (CCPA 1963). The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that 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. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). See MPEP §§ 2114 and 2173.05(g).
Regarding claim 72, Plante teaches the device of claim 61, wherein said container (receiving vessel 1) comprises at least one of: a tube (figure 1 shows the vessel 1 having an elongated tubular portion 5 as a tube; col. 5, lines 11 – 21), a flat bottom or a substantially flat bottom, and around bottom or a substantially round bottom.
Regarding claim 73, Plante teaches the device of claim 61, wherein said reagent comprises an enzyme, an enzyme inhibitor, a chelator, a buffering agent, or a combination thereof (it is implicitly anticipated that the special formula operable to stabilize and preserve a biological sample can comprise a buffering agent and/or an enzyme inhibitor; col. 5, lines 44 – 46).
Regarding claim 74, Plante does not specifically teach wherein said biological sample comprises a urine sample, but does teach that the device is suitable for use with biological samples, such as saliva samples (e.g., col. 1, lines 5 – 9). This claim is considered to be a statement of intended use or manner of operation. This claim does not further limit or define the claimed device structure as claimed. The prior art device is considered to be capable of being used in the manner claimed. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The recitation of a new intended use, for an old product, does not make a claim to that old product patentable. The Courts have held that if the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967); and In re Otto, 136 USPQ 458, 459 (CCPA 1963). The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that 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. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). See MPEP §§ 2114 and 2173.05(g).
Regarding claim 75, Plante teaches a method for collecting a biological sample of a subject (Abstract; col. 5, lines 1 – 66; col. 6, lines 11 – 37; figures 1 – 3), comprising:
(a) providing a container (receiving vessel 1) comprising a piercer (knife 19) extending across a longitudinal axis of said container towards an opening (entrance aperture 4) of said container, wherein said container comprises said biological sample (e.g., saliva; col. 6, lines 38 – 40);
(b) engaging a cap (sealing cap 2) with said container (vessel 1) to dispose said cap adjacent to said opening, wherein said cap comprises a pierceable container (liquid tight reservoir 12 comprising thin-film membrane or foil 13) comprising a reagent (reservoir 12 contains therein a special formula operable to stabilize and preserve biological samples; col. 5, lines 44 – 56) for processing or preserving said biological sample; and
(c) upon engaging said cap (cap 2) with said container (vessel 1), subjecting said cap or said container to a closing motion, thereby piercing, by said piercer (knife 19), said pierceable container (reservoir 12) to release said reagent into said container (col. 5, lines 1 – 66; col. 6, lines 17 – 37; figures 1 – 3).
Regarding claim 76, Plante teaches the method of claim 75, wherein said closing motion comprises rotating said container (vessel 1) or said cap (sealing cap 2). Plante teaches wherein said piercer (knife 19) pierces said pierceable container (reservoir 12) upon rotation of said cap (cap 2) or said container (vessel 1) (col. 5, lines 11 – 66; col. 6, lines 17 – 37; figures 1 – 3).
Regarding claim 77, Plante teaches the method of claim 75, wherein said closing motion comprises exerting a pressure on said cap towards said container or exerting a pressure on said container towards said cap (col. 6, lines 31 – 37; figures 1 – 3).
Regarding claim 78, Plante teaches the method of claim 75, further comprising closing said container at least in part by rotating said cap or said container (col. 5, lines 49 – 56).
Regarding claim 79, Plante teaches the method of claim 75, further comprising closing said container at least in part by exerting a pressure on said cap or said container (col. 6, lines 31 – 37).
Regarding claim 80, Plante teaches the method of claim 75, further comprising attaching said cap to said container thereby generating a leak-resistant, leak-proof, or airtight compartment (figure 3 shows cap 34 forming a tight seal via inside surface 35 with the vessel; col. 6, lines 17 – 37).
Regarding claim 81, Plante teaches the method of claim 75, wherein said cap and said container each comprises threading (thread seat 11 in sealing cap 2 and thread set system 8 in receiving vessel 1; figure 1 col. 5, lines 11 – 66), wherein said threading of said cap and said threading of said container are configured to interface together thereby closing said container (figure 1; col. 5, lines 49 – 56; col. 6, lines 31 – 37).
Regarding claim 82, Plante teaches the method of claim 75, wherein said piercer comprises a rod, wherein a top of said rod comprises a sharp protrusion (piercer comprising knife 19 which is considered a rod comprising a sharp end; figure 1).
Regarding claim 83, Plante teaches the method of claim 75, wherein said pierceable container is configured such that a pierceable surface of said pierceable container is exposed on a bottom surface of said cap (figure 1 shows the bottom surface of the cap 2 is exposed such that the pierceable portion (knife 19) of the container (vessel 1) is able to pierce the membrane 13 when the cap 2 is closed).
Regarding claim 84, Plante teaches the method of claim 75, further comprising mixing together said reagent and said biological sample, responsive to said releasing of said reagent into said container (the cap 2 is coupled to a reservoir 12 comprising a reagent and coupled to the container (receiving vessel 1), wherein the action of forming a seal between the cap and vessel cases the membrane 13 of the reservoir 12 containing the reagent to be breached. The reagent is then released and mixed with the sample already in the receiving vessel 1; col. 5, lines 1 – 66; col. 6, lines 17 – 37; figures 1 – 3).
Regarding claim 85, Plante teaches the method of claim 84, further comprising preserving, using said reagent, integrity of analytes in said biological sample, responsive to said mixing (col. 5, lines 44 – 46).
Regarding claim 86, Plante teaches the method of claim 85, wherein said analytes comprise nucleic acids, polypeptides, lipids, or carbohydrates (e.g., saliva samples can comprise nucleic acids, polypeptides, lipids and carbohydrates; col. 5, lines 44 – 46).
Regarding claim 87, Plante teaches the method of claim 85, further comprising assaying said preserved analytes (e.g., the device containing the collected biological sample is shipped to a laboratory for analysis; col. 4, lines 15 – 29).
Regarding claim 88, Plante teaches the method of claim 75, wherein said container (receiving vessel 1) comprises at least one of: a tube (figure 1 shows the vessel 1 having an elongated tubular portion 5 as a tube; col. 5, lines 11 – 21), a flat bottom or a substantially flat bottom, and around bottom or a substantially round bottom.
Regarding claim 89, Plante teaches the method of claim 75, wherein said reagent comprises an enzyme, an enzyme inhibitor, a chelator, a buffering agent, or a combination thereof (it is implicitly anticipated that the special formula operable to stabilize and preserve a biological sample can comprise a buffering agent and/or an enzyme inhibitor; col. 5, lines 44 – 46).
Regarding claim 90, Plante teaches the method of claim 75, further comprising providing said biological sample to said container (e.g., a biological sample comprising saliva is collected and provided to container (receiving vessel 1); col. 6, lines 38 – 51).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Takahashi et al. (US 2004/0036229 A1) teach a sealing cap mechanism for a vessel. Plante et al. (US 2012/0325721 A1) teach saliva sample collection systems. Becker et al. (US 2013/0164738 A1) teach genetic sample collection systems. Williams et al. (US 2021/0177385 A1) teach a method and apparatus for collecting and preserving a biological sample. Williams et al. (US 2021/0052257 A1) teach a biological sample collection system.
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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796