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 § 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.
Claims 4, 5, 11, 13, 19, 22, 24, 25, 31, 34, and 39 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.
The term “approximately the entire length” in claim 4 is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how much the groove extends down the length of the lower portion. The same issue is present in claim 24.
The term “approximately parallel” in claim 5 is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how something can be approximately parallel. The same issue is present in claim 25.
The term “approximately equal to an inner diameter of the sample tube” in claim 11 is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how something can be approximately equal. The claim is being interpreted as meaning that the outer diameter of the lower portion is configured to fit in the inner diameter of the sample tube. The same issue is present in claim 31.
Claim 13 recites the limitation "the sample vial". There is insufficient antecedent basis for this limitation in the claim. It is recommended the claim be amended to say “the sample tube”. The same issue is present in claim 33.
Claim 19 states that “each of the at least one identifier encodes the same information”. If the device has one identifier is unclear what the encoded information is the same as. The same issue is present in claim 39.
Claim 22 recites the limitation “The device of claim 21". There is insufficient antecedent basis for this limitation in the claim. It is recommended the claim be amended to say “The method of claim 21”.
Claim 34 recites the limitation "the chemical substance ". There is insufficient antecedent basis for this limitation in the claim. It is recommended the claim be amended to be dependent on claim 33.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-5, 8-9, 21-25, and 28-29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Skakoon (US 20150064080 A1).
In regards to claim 1 Skakoon teaches a sample collection device, comprising:
a hollow upper portion that tapers between a first open end and a second open end, the upper portion defining a sample collection volume (Fig 9 Header assembly 403);
a tubular lower portion extending along a longitudinal axis from the second open end to an open terminal end of the device, the lower portion defining a lumen in fluid communication with the sample collection volume and the open terminal end (Fig 9 insert 805);
and at least one groove extending inward from an outer surface of the lower portion, the at least one groove extending along at least a portion of a length of the lower portion (Fig 9 slots 809).
In regards to claim 2 Skakoon teaches the device of claim 1, wherein the hollow upper portion has a conical shape (Fig 9 Header assembly 403).
In regards to claim 3 Skakoon teaches the device of claim 1, wherein the at least one groove comprises a plurality of circumferentially spaced grooves (Fig 9 slots 809).
In regards to claim 4 Skakoon teaches the device of claim 1, wherein the at least one groove extends along approximately the entire length of the lower portion (Fig 9 slots 809).
In regards to claim 5 Skakoon teaches the device of claim 1, wherein the at least one groove extends approximately parallel to the longitudinal axis (Fig 9 slots 809).
In regards to claim 8 Skakoon teaches a sample collection kit comprising: the sample collection device of claim 1; a sample tube configured to couple to the sample collection device at an open end; and a cap configured to seal the open end of the sample tube (Fig 1 collection vessel 101 and cap 103).
In regards to claim 9 Skakoon teaches the kit of claim 8, wherein the sample collection device further comprises first threads positioned on an outer surface or inner surface of the upper portion at about the second end, and the sample tube further comprises second threads positioned on an inner surface or an outer surface at about the open end, wherein the first and second threads are configured to mate with one another to couple the sample collection device to the sample tube (See annotated Figure 9 below).
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Annotated Skakoon Fig 9
In regards to claim 21 Skakoon reaches A method of collecting a liquid sample from a patient, comprising: positioning a sample collection device adjacent to a lower lip of a patient, the sample collection device comprising:
a hollow upper portion that tapers between a first open end and a second open end, the upper portion defining a sample collection volume (Fig 9 Header assembly 403);
a tubular lower portion extending along a longitudinal axis from the second open end to an open terminal end of the device, the lower portion defining a lumen in fluid communication with the sample collection volume and the open terminal end (Fig 9 insert 805);
and at least one groove extending inward from an outer surface of the lower portion, the at least one groove extending along at least a portion of a length of the lower portion (Fig 9 slots 809).
receiving, within the sample collection volume, a saliva sample ([0057]);
receiving, within a sample tube coupled to the sample collection device, at least a portion of the saliva sample ([0057]);
decoupling the sample tube from the sample collection device after receipt of the saliva sample; and sealing the sample tube ([0057]).
In regards to claim 22 Skakoon teaches the method of claim 21, wherein the hollow upper portion has a conical shape (Fig 9 Header assembly 403).
In regards to claim 23 Skakoon teaches the method of claim 21, wherein the at least one groove comprises a plurality of circumferentially spaced grooves (Fig 9 slots 809).
In regards to claim 24 Skakoon teaches the method of claim 21, wherein the at least one groove extends along approximately the entire length of the lower portion (Fig 9 slots 809).
In regards to claim 25 Skakoon teaches the method of claim 21, wherein the at least one groove extends approximately parallel to the longitudinal axis (Fig 9 slots 809).
In regards to claim 28 Skakoon teaches the method of claim 21, further comprising coupling the sample collection device to the sample tube prior to receipt of the saliva sample ([0057]).
In regards to claim 29 Skakoon teaches the method of claim 28, wherein coupling the sample collection device to the sample tube comprises engaging first threads positioned on an outer surface of the upper portion at about the second end with mating second threads positioned on an inner surface of the sample tube (See annotated Figure 9 above).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 6-7, 10-12, 26-27, and 30-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Skakoon (US 20150064080 A1).
In regards to claim 6 Skakoon teaches the device of claim 1. Skakoon does not explicitly teach a device wherein the depth of the groove in the radial direction is from about 0.1 mm to about 1.0 mm. It is noted that Applicant has not disclosed in the specification that the claimed depth of the groove in the radial direction provides an advantage or unexpected result. As such, it would have been obvious, through routine experimentation, to determine a depth in the radial direction of the groove of Skakoon. Furthermore, “where 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In regards to claim 7 Skakoon teaches the device of claim 1. Skakoon fails to teach wherein the terminal end of the lower portion is beveled. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the lower portion of Skakoon to be beveled at the end. Doing so would merely be a change in shape. MPEP 2144.04.III
In regards to claim 10 Skakoon teaches the kit of claim 8. Skakoon does not explicitly teach a device wherein a length of the lower portion is dimensioned such that, when the sample collection device is coupled to the sample tube, the terminal end of the lower portion is distanced about 5 mm to about 20 mm from a base of the sample tube. It is noted that Applicant has not disclosed in the specification that the claimed length of the lower portion direction provides an advantage or unexpected result. As such, it would have been obvious, through routine experimentation, to determine a length of the lower portion of Skakoon. Furthermore, “where 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In regards to claim 11 Skakoon teaches the kit of claim 8. Skakoon does not explicitly teach a device wherein an outer diameter of the lower portion is approximately equal to an inner diameter of the sample tube. It is noted that Applicant has not disclosed in the specification that the claimed diameters provide an advantage or unexpected result. As such, it would have been obvious, through routine experimentation, to determine a diameter of the lower portion and sample tube of Skakoon. Furthermore, “where 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In regards to claim 12 Skakoon teaches the kit of claim 8. Skakoon does not explicitly teach a device wherein a total volume of the sample tube is within the range from about 0.5 mL to about 2.0 mL. It is noted that Applicant has not disclosed in the specification that the claimed volume provides an advantage or unexpected result. As such, it would have been obvious, through routine experimentation, to determine a total volume of the sample tube of Skakoon. Furthermore, “where 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In regards to claim 26 Skakoon teaches the method of claim 21. Skakoon does not explicitly teach a method wherein the depth of the groove in the radial direction is from about 0.1 mm to about 1.0 mm. It is noted that Applicant has not disclosed in the specification that the claimed depth of the groove in the radial direction provides an advantage or unexpected result. As such, it would have been obvious, through routine experimentation, to determine a depth in the radial direction of the groove of Skakoon. Furthermore, “where 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In regards to claim 27 Skakoon teaches the method of claim 21. Skakoon fails to teach wherein the terminal end of the lower portion is beveled. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the lower portion of Skakoon to be beveled at the end. Doing so would merely be a change in shape. MPEP 2144.04.III
In regards to claim 30 Skakoon teaches the method of claim 21. Skakoon does not explicitly teach a method wherein a length of the lower portion is dimensioned such that, when the sample collection device is coupled to the sample tube, the terminal end of the lower portion is distanced about 5 mm to about 20 mm from a base of the sample tube. It is noted that Applicant has not disclosed in the specification that the claimed length of the lower portion direction provides an advantage or unexpected result. As such, it would have been obvious, through routine experimentation, to determine a length of the lower portion of Skakoon. Furthermore, “where 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In regards to claim 31 Skakoon teaches the method of claim 21. Skakoon does not explicitly teach a method wherein an outer diameter of the lower portion is approximately equal to an inner diameter of the sample tube. It is noted that Applicant has not disclosed in the specification that the claimed diameters provide an advantage or unexpected result. As such, it would have been obvious, through routine experimentation, to determine a diameter of the lower portion and sample tube of Skakoon. Furthermore, “where 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In regards to claim 32 Skakoon teaches the method of claim 21. Skakoon does not explicitly teach a method wherein a total volume of the sample tube is within the range from about 0.5 mL to about 2.0 mL. It is noted that Applicant has not disclosed in the specification that the claimed volume provides an advantage or unexpected result. As such, it would have been obvious, through routine experimentation, to determine a total volume of the sample tube of Skakoon. Furthermore, “where 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 13-14, and 33-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Skakoon (US 20150064080 A1) as applied to claims 8 and 21, in view of Karmali (US 20050232813 A1).
In regards to claim 13 Skakoon teaches the kit of claim 8. Skakoon fails to teach a device wherein at least one of the sample collection device or the sample tube is coated with a chemical substance. Karmali teaches a sample collection tube coated with a stabilizing agent in order to prevent the components of interest from degrading ([0047]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the sample tube of Skakoon so that it is coated with a stabilizing agent like the sample tube of Karmali in order to prevent the sample from degrading.
In regards to claim 14 modified Skakoon teaches the kit of claim 13, wherein the chemical substance is selected from the group consisting of chelating agents, non-ionic or ionic detergents, proteins, enzymes, proteases, RNAse inhibitors, nucleic acids, buffers, salts, or chaotropic salts (Karmali [0047]).
In regards to claim 33 Skakoon teaches the method of claim 21. Skakoon fails to teach a method wherein at least one of the sample collection device or the sample tube is coated with a chemical substance. Karmali teaches a sample collection tube coated with a stabilizing agent in order to prevent the components of interest from degrading ([0047]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the sample tube of Skakoon so that it is coated with a stabilizing agent like the sample tube of Karmali in order to prevent the sample from degrading.
In regards to claim 34 modified Skakoon teaches the method of claim 33, wherein the chemical substance is selected from the group consisting of chelating agents, non-ionic or ionic detergents, proteins, enzymes, proteases, RNAse inhibitors, nucleic acids, buffers, salts, or chaotropic salts (Karmali [0047]).
Claim(s) 15, 17-20, 35, and 37-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Skakoon (US 20150064080 A1) as applied to claims 8 and 21, in view of Yong (US 20080058676 A1).
In regards to claim 15 Skakoon teaches the kit of claim 8. Skakoon fails to teach at least one identifier positioned on the sample tube, wherein the at least one identifier encodes information identifying a sample received within the sample tube. Yong teaches a barcode on a sample tube for use in identifying the sample ([0032] [0052]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the sample tube of Skakoon to include a barcode like Yong in order to identify the sample in the tube.
In regards to claim 17 modified Skakoon teaches the kit of claim 15, wherein the at least one identifier comprises a second identifier positioned on a sidewall of the sample tube (Yong [0032] [0052] Fig. 5 barcode 64).
In regards to claim 18 modified Skakoon teaches the kit of claim 15, wherein the at least one identifier comprises at least one of a barcode, alphanumeric text, or symbol (Yong [0032] [0052] Fig. 5 barcode 64).
In regards to claim 19 modified Skakoon teaches the kit of claim 15, wherein each of the at least one identifier encodes the same information (Yong [0032] [0052] Fig. 5 barcode 64, single barcode).
In regards to claim 20 modified Skakoon teaches the kit of claim 15, wherein the at least one identifier comprises a foreground on a background, wherein the foreground is a first shade, tint, or color and the background is a second shade, tint, or color different from the first shade, tint, or color (Yong [0032] [0052] Fig. 5 barcode 64).
In regards to claim 35 Skakoon teaches the method of claim 21. Skakoon fails to teach at least one identifier positioned on the sample tube, wherein the at least one identifier encodes information identifying a sample received within the sample tube. Yong teaches a barcode on the sample tube for use in identifying the sample ([0032] [0052]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the sample tube of Skakoon to include a barcode like Yong in order to identify the sample in the tube.
In regards to claim 37 modified Skakoon teaches the method of claim 35, wherein the at least one identifier comprises a second identifier positioned on a sidewall of the sample tube (Yong [0032] [0052] Fig. 5 barcode 64).
In regards to claim 38 modified Skakoon teaches the method of claim 35, wherein the at least one identifier comprises at least one of a barcode, alphanumeric text, or symbol (Yong [0032] [0052] Fig. 5 barcode 64).
In regards to claim 39 modified Skakoon teaches the method of claim 35, wherein each of the at least one identifier encodes the same information (Yong [0032] [0052] Fig. 5 barcode 64, single barcode).
In regards to claim 40 modified Skakoon teaches the method of claim 35, wherein the at least one identifier comprises a foreground on a background, wherein the foreground is a first shade, tint, or color and the background is a second shade, tint, or color different from the first shade, tint, or color (Yong [0032] [0052] Fig. 5 barcode 64).
Claim(s) 15-16, 18-20, 35-36, and 38-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Skakoon (US 20150064080 A1) as applied to claims 8 and 21, in view of Nagy (US 20200254442 A1).
In regards to claim 15 Skakoon teaches the kit of claim 8. Skakoon fails to teach at least one identifier positioned on the sample tube, wherein the at least one identifier encodes information identifying a sample received within the sample tube. Nagy teaches a barcode on a bottom of a sample tube for use in identifying the sample ([0026]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the sample tube of Skakoon to include a barcode like Nagy in order to identify the sample in the tube.
In regards to claim 16 modified Skakoon teaches the kit of claim 15, wherein the at least one identifier comprises a first identifier positioned on a base of the sample tube (Nagy [0026]).
In regards to claim 18 modified Skakoon teaches the kit of claim 15, wherein the at least one identifier comprises at least one of a barcode, alphanumeric text, or symbol (Nagy [0026]).
In regards to claim 19 modified Skakoon teaches the kit of claim 15, wherein each of the at least one identifier encodes the same information (Nagy [0026]).
In regards to claim 20 modified Skakoon teaches the kit of claim 15, wherein the at least one identifier comprises a foreground on a background, wherein the foreground is a first shade, tint, or color and the background is a second shade, tint, or color different from the first shade, tint, or color (Nagy [0026]).
In regards to claim 35 Skakoon teaches the method of claim 21. Skakoon fails to teach at least one identifier positioned on the sample tube, wherein the at least one identifier encodes information identifying a sample received within the sample tube. Nagy teaches a barcode on a bottom of a sample tube for use in identifying the sample ([0026]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the sample tube of Skakoon to include a barcode like Nagy in order to identify the sample in the tube.
In regards to claim 37 modified Skakoon teaches the method of claim 35, wherein the at least one identifier comprises a second identifier positioned on a sidewall of the sample tube (Nagy [0026]).
In regards to claim 38 modified Skakoon teaches the method of claim 35, wherein the at least one identifier comprises at least one of a barcode, alphanumeric text, or symbol (Nagy [0026]).
In regards to claim 39 modified Skakoon teaches the method of claim 35, wherein each of the at least one identifier encodes the same information (Nagy [0026]).
In regards to claim 40 modified Skakoon teaches the method of claim 35, wherein the at least one identifier comprises a foreground on a background, wherein the foreground on a background, wherein the foreground is a first shade, tint, or color and the background is a second shade, tint, or color different from the first shade, tint, or color (Nagy [0026]).
Claim(s) 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Skakoon (US 20150064080 A1), in view of Yong (US 20080058676 A1) as applied to claim 35, further in view of Evans (US 20200365241 A1).
In regards to claim 41 modified Skakoon teaches the method of claim 35. Modified Skakoon fails to teach retrieving the encoded information from the at least one identifier and decoding the encoded information to identify the saliva sample. Evan teaches scanning a barcode to access data relating to a biological sample. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the method of modified Skakoon to include a step of scanning the barcode like the method of Evans in order to retrieve identification and information relating to the saliva sample.
Claim(s) 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Skakoon (US 20150064080 A1), in view of Nagy (US 20200254442 A1)as applied to claim 35, further in view of Evans (US 20200365241 A1).
In regards to claim 41 modified Skakoon teaches the method of claim 35. Modified Skakoon fails to teach retrieving the encoded information from the at least one identifier and decoding the encoded information to identify the saliva sample. Evan teaches scanning a barcode to access data relating to a biological sample. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the method of modified Skakoon to include a step of scanning the barcode like the method of Evans in order to retrieve identification and information relating to the saliva sample.\
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY EPPERT whose telephone number is (571)270-0818. The examiner can normally be reached M-F 7:30-5:00 EST.
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/LUCY EPPERT/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791