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 Objections
Claims 2 and 6 are objected to because of the following informalities:
Claim 2 line 1 should recite “the cover and/or the collector…”;
Claim 6 lines 1-2 should recite “…the accessor device and the collection container…”. Appropriate correction is required.
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 1-18 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 1 recites the limitation "the container" in line 6. This creates confusion as to whether this is the same as the “collection container” presented in line 2 or if it is a different container. If they are the same, the examiner recommends amending line 6 to recite “the collection container”. It is noted that “the collection container” is used throughout the claims and this is the only instance of “the container”. If they are different, there is insufficient antecedent basis for this limitation in the claim. Claims 2-18 are rejected due to their dependence upon rejected claim 1.
Regarding claim 8, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 15 and 17, “the connector” is indefinite since the claims are not clear as to which “connector” from claim 13 they are referring to.
Claim 16 recites “wherein the connector comprises”, but it is unclear as to whether this is the connector on the collector or the connector on the puncture device. Therefore, the scope of the claim cannot be determined. The examiner recommends amended the claim with language added that clarifies which connector is being limited.
Claim 17 recites the limitation "the receptor of the sample collection container" in line 3. This creates confusion as there does not appear to be any “connector/receptor” on the “sample collection container”. If the applicant intended to disclose that the cylindrical member is retained within the receptor of the puncture device---, the examiner recommends changing the language to properly reflect the receptor is on the “puncture device”. If the “receptor” is indeed on the “sample collection container”, then there is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1-2, 6-7, 9-12, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller (US 20020132367 A1).
Regarding claim 1, Miller teaches a sample collection accessory device configured for attachment to an open end of a collection container, the accessory device comprising:
a cover [Fig. 9 Item 150] comprising (i) an inner portion configured for insertion into the collection container [Fig. 9 Item 130, see Fig. 9 showing Item 150 is partially inserted within Item 130] comprising a sidewall having an inner surface [Fig. 9 Item 160] defining a channel [Fig. 9 Item 223] through the accessory device and an outer surface [Fig. 9, the peripheral annular projection of 150] with an outer diameter sized to seal against an inner surface of a sidewall of the container [see Fig. 9], and (ii) an outer portion [Fig. 9 Item 156] extending radially outward from the inner portion configured to extend over an end of the sidewall of the collection container [see Fig. 9 Item 156 extends over Item 130]; and
a collector [Fig. 9 unlabeled needle that extends through Item 150 and directs Item A through Item 223] extending distally from the cover configured for directing a biological sample [Fig. 9 Item A] to the channel defined by the inner surface of the inner portion of the cover [see Fig. 9].
Regarding claim 2, Miller teaches the accessory device of claim 1, wherein the cover and/or collector comprise a flexible plastic material comprising one or more of silicone, polypropylene, low-density polyethylene, synthetic rubber, or natural rubber [0119 “…the closure maybe made of natural rubber elastomer…”].
Examiner Figure 2
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Regarding claim 6, Miller teaches the accessory device of claim 1, wherein the accessory device and collection container are configured for collection and storage of a capillary blood sample [0034 “In use, a fluid sample enters the assembly by needle. The needle penetrates the closure and the float of the separator. The sample enters the assembly through the needle and through the central passageway of the bellows and then into the body of the tube. The needle is withdrawn from the assembly and the septum of the closure and the float reseals”, 0040 “When the fluid sample is blood…”].
Regarding claim 7, Miller teaches accessory device of claim 1, wherein the collector comprises at least one of a scoop [see Examiner Figure 3 below for interpretation of Miller Fig. 9 showing the collector with a “scoop”], a funnel, or a capillary action member.
Examiner Figure 3
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Regarding claim 9, Miller teaches the accessory device of claim 1, wherein the collector comprises a scoop [See examiner Figure 3 above] comprising (i) a first portion connected to and extending from the inner portion of the cover for guiding the sample toward the inner portion of the cover [see Examiner Figure 4 below for interpretation of Miller Fig. 9 showing the first portion of the collector], (ii) a second portion opposite the first portion [see Examiner Figure 4 below for interpretation of Miller Fig. 9 showing the second portion of the collector], and (iii) a guiding surface extending between the first portion and the second portion [see Examiner Figure 4 below for interpretation of Miller Fig. 9 showing the guiding surface].
Examiner Figure 4
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Regarding Claim 10, Miller teaches the accessory device of claim 9, wherein the second portion of the scoop comprises a curved top edge, which curves in at least two dimensions [See Examiner Figure 3 above for interpretation of Miller Fig. 9 showing a scoop. The examiner notes that the “scoop” as shown in Miller Fig. 9 is being presented as a two-dimensional image and clearly is shown having a “scoop” shape].
Regarding claim 11, Miller teaches accessory device of claim 1, wherein the collector comprises a capillary action rod [Fig. 9, see unlabeled “rod” that extends through the cover, Item 150] mounted to the cover by a wall extending radially between an outer surface of the capillary action rod and the inner surface of the inner portion of the cover [see Fig. 9].
Regarding claim 12, Miller teaches the accessory device of claim 11, wherein the rod extends through the channel defined by the inner surface of the inner portion of the cover, and wherein the rod is hollow comprising an open first end [see examiner Figure 4, “first portion” being interpreted as a “open first end”], an open second end [see examiner Figure 4, “second portion” being interpreted as a “open first end”], and an annular sidewall extending between the first end and the second end [see examiner Figure 4, “first portion” being interpreted as a “open first end”, see also 0034 “…a fluid sample enters the assembly by needle. The needle penetrates the closure and the float of the separator. The sample enters the assembly through the needle and through the central passageway of the bellows and then into the body of the tube”].
Regarding claim 19, Miller teaches a collection assembly comprising:
a collection container [Fig. 13 Item 130] comprising an open first end [Fig. 13 Item 132], a second end [Fig. 13 Item 134], and an annular sidewall [Fig. 13 Item 136] extending between the first end and the second end [see Fig. 13], the annular sidewall of the collection container defining an interior reservoir [Fig. 13 Item 140] configured to receive a biological sample [Fig. 9 Item A]; and
an accessory device [Fig. 7, the examiner is interpreting the accessory device as the combination of Items 150 to 170 combined with the “collector” labeled on Examiner Figure 3] removably mounted to the open first end of the collection container, the accessory device comprising:
a cover [Fig. 9 Item 150] comprising (i) an inner portion configured for insertion into the collection container [Fig. 9 Item 130, see Fig. 9 showing Item 150 is partially inserted within Item 130] comprising a sidewall having an inner surface [Fig. 9 Item 160] defining a channel [Fig. 9 Item 223] through the accessory device and an outer surface [Fig. 9, the peripheral annular projection of 150] with an outer diameter sized to seal against an inner surface of a sidewall of the container [see Fig. 9], and (ii) an outer portion [Fig. 9 Item 156] extending radially outward from the inner portion configured to extend over an end of the sidewall of the collection container [see Fig. 9 Item 156 extends over Item 130]; and
a collector [Fig. 9 unlabeled needle that extends through Item 150 and directs Item A through Item 223] extending distally from the cover configured for directing a biological sample [Fig. 9 Item A] to the channel defined by the inner surface of the inner portion of the cover [see Fig. 9] and into the interior reservoir of the collection container [see Fig. 9].
Regarding claim 20, Miller teaches a method for automated blood sample processing, comprising:
mounting an accessory device [Fig. 7, the examiner is interpreting the accessory device as the combination of Items 150 to 170 combined with the “collector” labeled on Examiner Figure 3] to a collection container [Fig. 9 Item 130] by inserting an inner portion [Fig. 9 Item 172] of the accessory device though an open first end of the collection container [Fig. 13 Item 132], wherein the accessory device comprises:
a cover [Fig. 9 Item 150] comprising (i) the inner portion comprising a sidewall [Fig. 9 Item 158] having an inner surface [Fig. 9 Item 160] defining a channel [Fig. 9 Item 223] through the accessory device and an outer surface with an outer diameter sized to seal against an inner surface of a sidewall of the collection container [Fig. 9, the peripheral annular projection of 150] and (ii) an outer portion [Fig. 9 Item 156] extending radially outward from the inner portion configured to extend over the open first end of the collection container [see Fig. 9 Item 156 extends over Item 130]; and
a collector [see Examiner Figure 3 above] extending distally from the cover configured for directing the blood sample [Fig. 9 Item A] to the channel defined by the inner surface of the inner portion of the cover [see Fig. 9];
obtaining the blood sample by directing the blood sample through the collector and into an interior reservoir of the collection container through the channel defined by the inner portion of the accessory device [0034 “…a fluid sample enters the assembly by needle. The needle penetrates the closure and the float of the separator. The sample enters the assembly through the needle and through the central passageway of the bellows and then into the body of the tube”];
once the blood sample is obtained, removing the accessory device from the open first end of the collection container [0034 “The needle is withdrawn from the assembly and the septum of the closure and the float reseals”]; and
processing the obtained blood sample in the collection container using at least one automated processing device [0035 “The assembly is then subjected to centrifugation”, the examiner notes that “centrifugation” is disclosed by the applicant’s specification, par. 0157, as being an automated testing process].
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Miller as applied to claim 2 above, and further in view of Hindelang (US 20080243032 A1).
Regarding claim 3, Miller teaches the accessory device of claim 2, wherein the cover comprises a flexible plastic material, but fails to teach the flexible plastic material comprises additives for increasing wettability of surfaces of the accessory device.
Hindelang teaches the flexible plastic material comprises additives for increasing wettability of surfaces [0060 “…a hydrophobic or only very slightly hydrophilic surface can be hydrophilized by a suitable coating with a stable hydrophilic layer that is inert towards the sample material for example by covalently binding photoreactively equipped, hydrophilic polymers to a plastic surface by applying layers containing wetting agents or by coating surfaces with nanocomposites by means of sol-gel technology”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Miller and incorporate the teachings of Hindelang to include the flexible plastic material comprises additives for increasing wettability of surfaces of the accessory device. Doing so configures the system to be “…not able to itself absorb the sample liquid or only to an insubstantial extent”, therefore allowing more of the sample to be collected and not absorbed into the cover.
Regarding claim 8, Miller teaches accessory device of claim 1, wherein Miller teaches the cover and collector, but fails to explicitly teach the cover and the collector are an integral part formed by a single molding process, such as injection molding.
Hindelang teaches the cover and the collector are an integral part formed by a single molding process, such as injection molding [0075 “…injection-molding the plastic body (protective cap) including embedding: the lancet needle (optionally while generating the "needle head"].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Miller and incorporate the teachings of Hindelang to include the cover and the collector are an integral part formed by a single molding process, such as injection molding. Doing so configures the system to have reduced assembly costs/time, stronger material bonding, and higher production efficiency than requiring separate components.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Miller.
Regarding claim 4, Miller teaches the accessory device of claim 1, wherein Miller teaches an inner portion wherein the second end of the inner portion is configured to be inserted into the collection container [see Fig. 9 where Item 150 is within Item 130], but fails to teach wherein the inner portion of the cover is tapered, with an outer diameter of a first end of the inner portion being wider than an outer diameter of a second end of the inner portion.
However, a different embodiment of Miller teaches the inner portion of the cover is tapered [Fig. 5, the “inner portion” being the part of Item 50 within the container Item 40], with an outer diameter of a first end of the inner portion [see Examiner Figure 1 below for interpretation of Miller Fig. 5] being wider than an outer diameter of a second end of the inner portion [see Examiner Figure 1 below for interpretation of Miller Fig. 5].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the embodiments of Miller to teach wherein the inner portion of the cover is tapered, with an outer diameter of a first end of the inner portion being wider than an outer diameter of a second end of the inner portion. Doing so configures the “inner portion” with physical dimensions that reduce the difficulty of insertion of the apparatus into the sample container while also maintaining enough width to seal the sample within the container.
Examiner Figure 1
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Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Miller as applied to claim 1 above, and further in view of Kacian (7,691,332).
Regarding claim 5, Miller teaches the accessory device of claim 1, wherein the outer portion comprises a first end [see Examiner Figure 2 below for interpretation of Miller Fig. 9 showing a first end] connected to a first end of the inner portion [see Examiner Figure 1 below for interpretation of Miller Fig. 9 showing a first end of the inner portion], a second end [see Examiner Figure 2 below for interpretation of Miller Fig. 9 showing a second end], and an annular sidewall [Fig. 9 Item 158] extending between the first end and the second end of the outer portion [see Fig. 9], but fails to teach an outer surface of the inner portion and an inner surface of the sidewall of the outer portion define an annular slot sized to receive a lip feature extending from the open end of the collection container.
Kacian teaches an outer surface of the inner portion [Fig. 4 Item 41] and an inner surface of the sidewall of the outer portion [Fig. 4 Item 36/37] define an annular slot sized to receive a lip feature [Fig. 4 Item 58/60] extending from the open end of the collection container [see Fig. 4].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Miller and incorporate the teachings of Kacian to include an outer surface of the inner portion and an inner surface of the sidewall of the outer portion define an annular slot sized to receive a lip feature extending from the open end of the collection container. Doing so configures the system to provide a more secure connection of the sample container to the accessory device so as to prevent unwanted/unnecessary movement of the components.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Miller as applied to claim 1 above, and further in view of Deckler (US 20230055314 A1).
Regarding claim 13, Miller teaches the accessory device of claim 1, wherein the collector comprises a tubular body [see Examiner Figure 3 above for interpretation of Miller Fig. 9 showing a “collector”] defining a channel configured to guide the sample to the channel of the cover [Miller 0034 “The sample enters the assembly through the needle and through the central passageway of the bellows and then into the body of the tube”] and removably connecting the collector to the accessory device [Miller 0034 “The needle is withdrawn from the assembly and the septum of the closure and the float reseals”], but fails to teach a connector on an exterior portion of the collector configured to engage a corresponding connector of a puncture device connecting the puncture device to the accessory device.
Deckler teaches a connector on an exterior portion of the collector configured to engage a corresponding connector of a puncture device connecting the puncture device to the accessory device [see Examiner Figure 5 below for interpretation of Deckler Fig. 1].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Miller and incorporate the teachings of Deckler to include a connector on an exterior portion of the collector configured to engage a corresponding connector of a puncture device connecting the puncture device to the accessory device. Doing so configures the system to replace and/or remove parts to facilitate a more accessible means to clean and/or replace contaminated or unneeded components, thereby improving device handling and lowering repair costs by enabling only a component of the system as a whole to be replaced.
Regarding claim 14, Miller and Deckler teach the accessory device of claim 13, wherein, when engaged to the connector on the exterior portion of the collector, the puncture device is positioned over the channel defined by the tubular body for directing the biological sample through the tubular body and cover into an interior reservoir of the collection container [Deckler 0077 “…the fracturable element 122 is located at the bottom of the blood collection apparatus opposite the test tube septum 112 which is located on the top of the blood collection apparatus (the blood collection apparatus is illustrated upside down)”, the examiner notes that with the recitation from par. 0077, the “puncture device” of Figure 1 would be above the “channel” which leads into the “sample container”].
Regarding claim 16, Miller and Deckler further teach wherein the connector is configured to rotatably engage the puncture device, such that the puncture device is movable from a pre-use position, where the puncture device is spaced apart from the open end of the collection container, to an in-use position, wherein the puncture device covers the open end of the collection container.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Miller and Deckler as applied to claim 14 above, and further in view of Dassa (US 6730071 B1).
Regarding claim 15, Miller and Deckler teach the accessory device of claim 14, wherein the biological sample moves from the puncture device [as taught by Deckler, see Examiner Figure 5] through the tubular body [see Deckler Figure 1, unlabeled tubing joining Item 194 to Item 192] of the connector [See Examiner Figure 5 above] and cover [Deckler Figure 1 Item 191] into the interior reservoir of the collection container [Deckler Fig. 1 Item 112, see also Deckler 0001 “…this disclosure relates to apparatuses for and methods of collecting blood into a test tube…”], but fails to explicitly teach the sample moves by gravity.
Dassa teaches a similar system in the same field of endeavor in which the sample moves by gravity [col. 3 lns. 44-47].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Miller and Deckler and incorporate the teachings of Dassa to include the sample moves by gravity. Doing so configures the system to utilize a blood collection method that reduces the risk of overfilling or underfilling as well as minimizing hemolysis risk compared to other systems, such as vacuum tubes.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bokka Srinivasa Rao (US 20190223772 A1) which discloses attaching an accessory device comprising a hollow needle to a test tube, but fails to teach a connector on an exterior of the collector configured to engage a corresponding connector of a puncture device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HANEY whose telephone number is (571)272-0985. The examiner can normally be reached Monday through Friday, 0730-1630 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571)272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN M HANEY/ Examiner, Art Unit 3791
/ALEX M VALVIS/ Supervisory Patent Examiner, Art Unit 3791
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