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.
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 39 and 40 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.
Claims 39 and 40 are indefinite for being dependent on a cancelled claim. For the purpose of examination, the claims will be interpreted as dependent on claim 21.
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.
Claims 21-27 and 29-38 are rejected under 35 U.S.C. 102 (a)(1) as being
anticipated by Holmes et. al. (WO2017062892A1).
Regarding claim 21, Holmes teaches “A bodily fluid collection assembly,
the assembly comprising:” (Title, Bodily fluid sample collection and transport):
“a fluid extraction device comprising a fluid extraction system, wherein the
fluid extraction system is configured to extract a fluid from a user;” (Para
[00176] and [00177], The sample receiving end 226 of the device may be
contacted to a sample. The sample may be provided directly from the
subject. Sample receiving end 326 of the device.);
“a first aperture for output of fluid from the fluid extraction device; and at least a channel from the fluid extraction system to the aperture,” (Fig. 3b and Para [00191] In one embodiment, the engagement assembly may house an adapter channel 354 such as but not limited to an elongate member with angled, tapered or pointed
end 327a and 327b. It should be understood that in some embodiments, the
ends 327a and 327b are part of a needle that is formed separate from
the channels 322a and 322b and then coupled to the channels 322a and 322b.).
Therefore the needle and the engagement assembly is the first aperture and the
channels are the at least a channel.
The recitation “the at least a channel configured to permit extracted fluid to
flow from the fluid extraction system to the aperture;” is a capability of the
channel however taught within (Para [00177] Figures 3A-3B show an example of
a sample collection device 300 prior to bringing the channels 322a, 322b
into fluid communication with one or more vessels 346a, 346b. Blood may travel
along the length of the channels to the respective second ends 325a, 325b of
the channels.).
Further taught “and a collection tube, wherein the collection tube further
comprises: a proximal end having an opening into an interior of the tube,
the proximal end configured to fluidically connect to the aperture;” (Fig. 3b
and Para [00183] In some embodiments, each vessel may have a body 349a,
349b and a cap 348a, 348b.);
“a chemical lining within the interior of the tube, the chemical lining including at least an anticoagulant agent;” (Para 00434, It should be understood that the holding chambers 2018 and 2020 and/or the vessels 1146a and 1146b may contain anti-coagulant therein to prepare the sample fluid for processing.);
“and a distal end” (Fig. 3b, distal end of 346a and 346b).
The recitation “configured to be compressible for ejection of fluid from the
collection tube.” is capability of the distal end. Holmes discloses the positively
claimed structural elements of the distal end of the collection tube as claimed,
since the collection tube distal end is fully capable of the recited adaption
in as much as recited and required herein.
Regarding claim 22, Holmes teaches all of claim 21 as above in addition to
“wherein the tube comprises an outer body,” (Fig. 3b and Para [00197], each
vessel may have a body 449a, 449b) “wherein the outer body comprises a
plurality of ridges projecting from the outer body.” (Para [00379], In one
embodiment, a sample vessel body may have an interior surface and an exterior
surface. The surfaces of the sample vessel body may be smooth, rough,
textured, faceted, shiny, dull, contain grooves, contain ridges).
Regarding claim 23, Holmes teaches all of claim 21 as above in addition to
“wherein the collection device further comprises a cap configured to cover
the proximal end of the tube.” (Fig. 3b and Paras [00183] and [00200], cap
348a, 348b. The cap may be configured to fit over an open end of the vessel.).
Regarding claim 24, Holmes teaches all of claim 23 as above in addition to “a
fastener connecting the cap to the tube.” (Para [00187], some embodiments
may include an additional part in the vessel assembly such as cap holder. In one
embodiment, the purpose of the cap holder is to maintain a tight seal between
the cap and vessel.)
Regarding claim 25, Holmes teaches all of claim 23 as above in addition to
“wherein the cap comprises a push-on cap.” (Para [00464], pressure from a
cap with a seal around the device being slid over the collection device).
Regarding claim 26, Holmes teaches all of claim 23 as above in addition to
“wherein the cap comprises a distal portion comprising an opening,
wherein the opening is configured to allow fluid to flow through it.” (Para
[00187] and [00157], Alternatively, the cap may permit certain gases and/or
liquids to pass through. Some embodiments may include vents pathways
(permanently open or operably closable) in the cap while others do not.).
Regarding claim 27, Holmes teaches all of claim 21 as above in addition to “wherein the chemical lining further comprises a temperature-stabilizing
gel.” (Para [0017], In yet another embodiment described herein, methods are
provided for shipping small volume sample vessels using a transport container
with integrated thermal control unit and/or material that provides active and/or
passive cooling. In one embodiment, the thermal control material may be but is
not limited to embedded phase change material (PCM) material that maintains
the temperature at a prior, or desired temperature.). Therefore the embedded
phase change material is the temperature-stabilizing gel.
Regarding claim 29, Holmes teaches all of claim 21 as above in addition to
“wherein the chemical lining comprises a chemical stabilizer.” (Para
[00620], In embodiments, the first vessel may contain a first anticoagulant (e.g.
EDTA)).
Regarding claim 30, Holmes teaches all of claim 21 as above in addition to
“wherein the chemical lining comprises an antioxidant.” (Para [0014], anti-
coagulating agent prior to, or during, transport to or into a sample vessel. In
embodiments, an anti-coagulating agent may be selected from the group
consisting of heparin (e.g. lithium heparin or sodium heparin),
ethylenediaminetetraacetic acid, 4-hydroxycoumarins, vitamin K antagonist
(VKA) anticoagulant, an anti-coagulant, or other additive.). Therefore
ethylenediaminetetraacetic acid is an antioxidant.
Regarding claim 31, Holmes teaches all of claim 21 as above in addition to
“wherein the fluid extraction device further comprising a housing
configured to encapsulate at least a portion of the fluid extraction device,
wherein the housing is portable.” (Figs 1A-1B and para [00158], One embodiment of a sample collection device 100 will now be described. In this non-
limiting example, the sample collection device 100 may include
a collection device body 120, support 130, and base 140. In some instances, a
cap 110 may be optionally provided.). Therefore the cap 110 and the body 120
and the support is the housing. The portability of the housing is capability
however taught within the housing being removed within Fig. 11V and the device
being moved to a different location within #1250.
Regarding claim 32, Holmes teaches all of claim 31 as above in addition to
“wherein the housing further comprises a first housing and second
housing, and the second housing is placed on atop of the first housing.”
(Fig. 1B, numbers 110, 120, and 130 on top of each other). Therefore 110 the
cap is the first housing and the second housing is the body 120 and the support
130.
Regarding claim 33, Holmes teaches all of claim 31 as above in addition to
“further comprising an assay component” (Para [0077], In embodiments
provided herein involving performing at least a portion of a laboratory test in an
assay unit, in embodiments, the assay unit maybe movable, such as by
a fluid handling apparatus. In embodiments including two or more assay units, in
embodiments, the assay units may be independently movable.).
The recitation “configured to be removably inserted into the fluid extraction
device a second aperture of the housing.” is capability of the assay
component. Holmes discloses the positively claimed structural elements of the
assay component as claimed, such assay component is said to be fully capable
of the recited adaption in as much as recited and required herein.
Regarding claim 34, Holmes teaches all of claim 21 as above in addition to
“comprising a sample card configured to receive fluid from the collection
tube.” (Para [00339], This embodiment shows a cartridge 1400 with a
sample collection device 1402 integrated therein.).
Regarding claim 35, Holmes teaches all of claim 21 as above in addition to
“wherein the fluid extraction system includes a mechanical skin piercing
component.” (Para [00510], Figure 46 shows a still further embodiment of a
sample collection device 3570. This embodiment described herein has a tissue
penetrating portion 3572 such as but not limited to a hypodermic needle with a
handling portion 3574.).
Regarding claim 36, Holmes teaches all of claim 35 as above in addition to
“wherein the mechanical skin piercing component further comprises a
plurality of microneedles.” (Para [00318], In one embodiment, these tissue
penetrating members are microneedles 1242).
Regarding claim 37, Holmes teaches all of claim 35 as above in addition to
“comprising an actuator configured to actuate the mechanical skin piercing
component.” (Para [00303], An actuation mechanism 1214 such as but not
limited to a spring actuator can be used to launch the tissue penetrating
member.).
Regarding claim 38, Holmes teaches all of claim 37 as above in addition to
“wherein the actuator further comprises a manual push-button.” (Para
[00303], [00313] and [00315], Figure 11R shows the actuation mechanism
1214 in a resting state and that it can be a spring that can be compressed to
launch a tissue penetrating member 1212 towards target tissue. When the drive
mechanism 1224 is a spring, the spring can be compressed to move the tissue
penetrating member 1222 to a launch position and the released to penetrate into
the target tissue. Figure 1 IS shows the tissue penetrating member 1222 in a
resting position. Figure 1 IT shows that in one embodiment of the
sample collection device, a firing button 1234 may be mounted on the
sample collection device 1230.).
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness
under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating
obviousness or nonobviousness.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Holmes et.
al. (WO2017062892A1) as applied to claim 21 and in further view of Lee et. al. (WO
2021217174 A1).
Regarding claim 28, Holmes teaches all of claim 21 above but does not teach
“wherein the chemical lining further comprises an anti- foaming agent.”.
Lee teaches clinical specimen collection in addition to “wherein the chemical lining further comprises an anti- foaming agent.” within (Para [0060], The transport media of the present disclosure were tested with a wide variety of sample matrices (including, but not limited to, stool, urine, simulated nasal fluid, and simulated STI matrix). The optional antifoaming agent makes transportation and liquid handling much easier and reduces the amount of foaming, as well as reduces error from automated liquid handling.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Holmes to incorporate the teachings of Lee wherein the chemical lining comprises an anti-foaming agent. Doing so would make transportation of the liquid handling easier and reduce foaming as taught by Lee. The present claims in addition to Holmes teach to a portable device therefore the liquid is being transported and the addition of the anti-foaming agent would be needed to reduce foaming and reduce errors as taught by Lee.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Holmes et.
al. (WO2017062892A1) as applied to claim 21 and in further view of Anderson (US
20190168210 A1).
Regarding claim 39, Holmes teaches all of claim 21 as above but does not
explicitly teach “further comprising a plasma separation card.”. However,
Holmes teaches within Paras [00594] and [0067], a process including
plasma separation of the sample at a sample collection location. In addition to a
cartridge may comprise all of the reagents necessary to perform all of
the tests that are to be performed with the sample(s) in the cartridge.
Anderson teaches devices and methods for sample collection in addition to
“further comprising a plasma separation card” (Paras [0052], [0036], [0056],
[0025], The components of clotting blood (plasma, cells and coagulum) may be
differentially transported in the paper as the blood drop spreads out, leading to
differences in composition at different points in the dried drop, further
complicating measurement of true blood concentrations of biomarkers.
Plasma recovery can be achieved by applying and removing solvents (e.g.,
aqueous buffers) to the outside of the sample vessel, by applying solvents to the
inside of the sample vessel (e.g., flowing through the lumen) to recover the blood
cell contents, or by a variety of other strategies. Plasma separation card. The
components of clotting blood (plasma, cells and coagulum) may be differentially
transported in the paper as the blood drop spreads out, leading to differences in
composition at different points in the dried drop, further complicating
measurement of true blood concentrations of biomarkers.)
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Holmes to incorporate the
teachings of Anderson to have a plasma separation card. Doing so
would allow the sample to be separated using the plasma separation card and
then be applied to the paper. Anderson highlights the issue of drying out
clotted blood being hard to transfer to paper and will cause different parts to dry
differently and affects the measurement of the true blood concentrations.
Allowing the sample to have plasma separation first would alleviate the issue
pointed out by Anderson.
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Holmes et.
al. (WO2017062892A1) as applied to claim 21 and in further view of Nelson et. al. (US
20180021026 A1).
Regarding claim 40, Holmes teaches all of claim 21 as above but does not
explicitly teach “wherein the distal end of the tube further comprises a
bulb”. However Holmes does teach within (Para 00520], a capillary tube) which
is often associated with at bulb on one end.
Nelson teaches a self-contained sampling device for processing whole blood in
addition to “wherein the distal end of the tube further comprises a bulb”
(Abstract and [0038], A collection device is disclosed having a tubular housing
detachably receiving a valved bulb reservoir at a first end thereof, the housing
having a second end for dispensing fluids. The valved bulb reservoir has a
sample capillary tube attached at one end thereof. Squeezing bulb 24 may then
express the analytic fluid(s) through outlet 38 into capillary 14.).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Holmes to incorporate the
teachings of Nelson wherein the distal end of the tube further comprises a bulb. Doing so would allow the bulb to be squeezed which would help the fluid move
as taught by Anderson.
Conclusion
Any inquiry concerning this communication or earlier communications from the
examiner should be directed to VELVET E HERON whose telephone number is
(571)272-1557. The examiner can normally be reached M-F.
Examiner interviews are available via telephone, in-person, and video
conferencing using a USPTO supplied web-based collaboration tool. To schedule an
interview, applicant is encouraged to use the USPTO Automated Interview Request
(AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
supervisor, Charles Capozzi can be reached on (571) 270-3638. The fax phone
number for the organization where this application or proceeding is assigned is 571-
273-8300.
Information regarding the status of published or unpublished applications may be
obtained from Patent Center. Unpublished application information in Patent Center is
available to registered users. To file and manage patent submissions in Patent Center,
visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-
center for more information about Patent Center and
https://www.uspto.gov/patents/docx for information about filing in DOCX format. For
additional questions, contact the Electronic Business Center (EBC) at 866-217-9197
(toll-free). If you would like assistance from a USPTO Customer Service
Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/V.E.H./
Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
Prosecution Insights