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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
Claims 1-13 are pending.
Claims 14 and 15 have been withdrawn.
Claims 1, 2, 5, 6, 7, 9, 10, 12 have been amended.
Claim Objections
Claim 7 is objected to because of the following informalities:
Claim 7 recites “the second reservoir is a centrally in the inner volume of the rotationally symmetric container”. The recitation should read as “the second reservoir is centered in the inner volume of the rotationally symmetric container”
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 6 and 7 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 6 recites “the fins of the rotationally symmetric container are angled towards the upper side of the rotationally symmetric container” however it is unclear which part of the fin is angled towards the upper side of the container.
Claim 7 recites the limitation "the rotationally symmetric container arranged duct". There is insufficient antecedent basis for this limitation in the claim. The limitation will be interpreted as “the second reservoir is centered in the inner volume of the rotationally symmetric container arranged to form a ventilation duct” in light of applicant’s specification (Spec., para [0054], [0058]).
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.
Claims 1, 2, 6 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Ramstad et. al. (US 20160089668 A1) in view of Beckbissingerde et. al. (DE 102013214859 A1), English translation and Elizarov et. al. (KR 20080044306 A), English translation.
Regarding claim 1, Ramstad teaches “A system for providing fluids,” (Title, Fluidic cartridges, systems).
Ramstad teaches two components and the first being a container within (Para [0020], FIG. 9 illustrates an alignment stage of a mating operation between a portion of the fluidic cartridge of FIG. 2 and a portion of the system base). Therefore, the fluidic cartridge is the first component.
Ramstad does not explicitly teach the container being a rotationally symmetric container as recited within “comprising two components, wherein – a first component is a rotationally symmetric container”.
However, Beckbissingerde teaches a sample container, sampling device and a seal. In addition to, “comprising two components, wherein – a first component is a rotationally symmetric container”. (Page 5, The following direction, for example, when the container body has an at least partially rotationally symmetrical, such as conical or cylindrical, sample receiving volume, an axial direction along the rotational axis of symmetry (cone axis, cylinder axis)).
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 Ramstad to incorporate the teachings of Beckbissingerde wherein the container is rotationally symmetric. Doing so provides for a container to be use with a system which rotates the container about an axis allowing the container to be move to its optimal location without the need of moving other parts within the device. Having a container which is cylindrical in shape which is classified as a rotationally symmetric container is well known in the art.
Ramstad further teaches “with at least one first reservoir for taking up a fluid and” ([0053] and Fig 1, having reservoirs 125 may be exposed so that liquids may be provided to the reservoirs 125);“a second reservoir for ventilation of the system,” ([0096] and Fig. 1 and Fig. 2, reservoirs 125, the reservoir 212 may be vented to enable full transfer of the liquid 340. For example, a vent or hole may be provided within the cover (not shown) of the fluidic cartridge 200. reservoirs 125.); “wherein said first and second reservoir are sealed with a seal, and” (Para [0030], The reservoirs may be in flow communication with transfer tubes that are operably coupled to movable seals.); “- a second component which is a dock for taking up the rotationally symmetric container,” ([0020] and Fig. 1, 102, FIG. 9 illustrates an alignment stage of a mating operation between a portion of the fluidic cartridge of FIG. 2 and a portion of the system base).
Ramstad does not explicitly teach “wherein the dock comprises an inner bottom surface comprising first formations for fluid piercing of the rotationally symmetric container's at least one first reservoir for taking up a fluid and second formations for piercing of the rotationally symmetric container's second reservoir for ventilation”. However, Ramstad does teach piercing of the seal by the cartridge (container) when movement of the system base happens within (Fig. 1, [0008], and [0011], the base projections 134 and 136 on the system base which allow transfer of fluid when the fluidic cartridge are mated with the system base and the transfer tube and movable seal is engaged with the base projections.) In addition to teaching the system being vented by use of a hole as stated in claim 1, ([0096] and Fig. 1 and Fig. 2, reservoirs 125, the reservoir 212 may be vented to enable full transfer of the liquid 340. For example, a vent or hole may be provided within the cover (not shown) of the fluidic cartridge 200. reservoirs 125.)) Therefore, it would have been within the ordinary skills of an artisan before the effective filing date of the claimed invention to have modified the invention of Ramstad by having the system base (dock) comprise fluid piercing of the container seals, since the piercing does not happen until the movement of the system base (dock) and the system base (dock) has a location in which a piercing feature could be attached. This piercing would create a hole which is taught useful in venting the system.
It would have been a matter of an obvious engineering choice, to better adjust the system base (dock) to accommodate formations for piercing. In addition, having the formations on the system base (dock) would decrease the chance of contamination within the cartridge (container).
Ramstad further teaches “wherein said inner bottom surface is a drain plate comprising a drain,” (Fig. 1 and Para [0056], a waste reservoir 158 connected using the fluidic network 152).
Ramstad does not explicitly teach “wherein the rotationally symmetric container has fins on its outer edge which engage into two parallel arranged recesses at the inner side surface of the dock for fixing the rotationally symmetric container within the dock in a first position when the fins of the rotationally symmetric container engage in a first recess which is a storage snap fit or a second position when the fins of the rotationally symmetric container engage in second recess at the inner side surface which is a retain snap fit.”
However, Ramstad does teach a locking mechanism can be used to maintain engagement between the fluidic cartridge and the system base (Para [0090] and [0092-0094], Although not shown, a locking mechanism (e.g., clamp) may be used to maintain the engagement between the fluidic cartridge 200 and the system base 320 throughout operation. As shown, the outer surface 258 of the container body 244 or the retaining element 245 may interface with the surface 328 of the system base 320. In the final displaced position, the fluidic port 232 has cleared the seal membrane 272 such that the liquid 340 is permitted to flow through the fluidic port 232 of the transfer tube 242 and into the fluidic port 326 of the system base 320. The fluidic cartridge 200 and the system base 320 may include complementary alignment features (e.g., pins and holes, ribs and grooves, etc.). that may be used to ensure alignment between the fluidic cartridge 200 with the system base 320.)
Elizarov teaches a fluidic structure is provided wherein mechanical actuation is conferred using a pin to actuate a flexible layer to occlude fluid flow in a fluid channel in addition to having fins between the container and dock (Pages 3, 6, 7 and Fig. 6, a variety of materials that can be used as pins, it may be desirable to use through-hole fins (e.g., through-hole metal tubes) or any shape that is not sharp. Actuating one fin to drive said second layer such that said second layer occludes said at least one fluidic channel. The fin plate 205 which houses the fins 10 is mounted on the flow structure above the flow device 215.) Therefore, having the fins between the flow device and having them drive the second layer which closes a fluidic channel teaches to the fins joining two components such as (container and dock).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ramstad to incorporate the teachings of Elizarov wherein the fins are located within the container which engage with the dock. Doing so would allow the system to securely lock in place and decrease the changes of contamination and leaking.
Regarding claim 2, Ramstad teaches all of claim 1 in addition to “wherein the first and second reservoir are sealed with a single seal.”. (Para [0065], After filling the liquids within the corresponding reservoirs 212, a cover (not shown) may be applied to the non-mating side 204 to seal the liquid containers 210 at one end. The cover may be similar to the cover 122 (FIG. 1).
Regarding claim 6, modified Ramstad teaches all of claim 1 above but does not explicitly teach “wherein the fins of the rotationally symmetric container are angled towards the upper side of the rotationally symmetric container.”. However Ramstad does teach that it is known to include a locking mechanism between the base and the container (fluidic cartridge) . Absent a showing of criticality or unexpected results, it would also be an obvious choice to have the container have fins angled towards the upper side of the container in order to connect to the dock (system base).
Regarding claim 8, modified Ramstad teaches all of claim 1 above but does not explicitly teach “wherein the fins are made of an elastic material.” However, Ramstad does teach elastic materials are used at the interface of the base and the fluidic cartridge to aid in sealing. Therefore it would have been clearly within the ordinary skills of an artisan before the effective filing date of the claimed invention to have modified the invention of Ramstad by having fins made of elastic material, since Ramstad does teach elastic material which is used in the sealing of the two components. In addition, having a fin which is elastic provides a device in which the system is able to form a locking seal when the two components are matted together.
Regarding claim 11, modified Ramstad teaches all of claim 1 as above in addition to “comprising further reservoirs for fluids.” (Para [0030] and [0063], Each of the reservoirs 212, The fluid-interconnect assemblies and fluidic cartridges may include reservoirs that hold a liquid. The reservoirs may be in flow communication with transfer tubes that are operably coupled to movable seals.).
Regarding claim 12, modified Ramstad teaches all of claim 1 as above in addition to “comprising formations for fluid piercing with different heights for a fluid release depending from the position of the rotationally symmetric container in the dock.” (Para [0089], As shown, the base projection 324 extends a height 325 from the surface 328. The height 325 may be configured relative to a desired displacement distance of the movable seal 223 and to achieve a desired compression of the movable seal 223 after the mating operation). Therefore, when the base system (dock) is moved for the mating operation with the cartridge (container) the heights are different.
Regarding claim 13, modified Ramstad teaches all of claim 1 as above in addition to “wherein each reservoir has a separate seal.” (Fig. 1 and [0055], seals 144 and 146).
Claims 3, 4, 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Ramstad et. al. (US 20160089668 A1) in view of Beckbissingerde et. al. (DE 102013214859 A1), English translation and Elizarov et. al. (KR 20080044306 A), English translation as applied to claim 1 and in view of Boehm et. al. (US 10416054 B2).
Regarding claim 3, Ramstad teaches all of claim 1 as above but does not teach “wherein the seal is a foil.”
Boehm teaches “wherein the seal is a foil.” (Column 12 lines 34-35, This creates depressions in the formed 35 portion 1202 that are then sealed in the back with a foil 1204).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ramstad to incorporate the teachings of Boehm wherein the seal is foil. Doing so would allow for decreased chances of evaporation of the fluid within the reservoir.
Regarding claim 4, Ramstad teaches all of claim 1 as above but does not teach “wherein the second reservoir is centrally arranged and surrounded by the at least one first reservoir.”
Boehm teaches “wherein the second reservoir is centrally arranged and surrounded by the at least one first reservoir.” (Fig. 4 and Abstract, the capillary structure which has a curved portion and an outer channel 410 and central region 408).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ramstad to incorporate the teachings of Boehm the second reservoir is centrally arranged and surrounded by the at least one first reservoir. Doing so allows for a more compact system in addition to allowing the reservoir with the vent to be in close contact with the reservoir with the fluid.
Regarding claim 7, modified Ramstad teaches all of claim 1 as above but does not teach “wherein the second reservoir is a centrally in the inner volume of the rotationally symmetric container arranged duct.”
Boehm teaches “wherein the second reservoir is a centrally in the inner volume of the rotationally symmetric container arranged duct.” (Fig. 4 and Abstract, the capillary structure which has a curved portion and an outer channel 410 and central region 408).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ramstad to incorporate the teachings of Boehm the second reservoir is centrally arranged and surrounded by the at least one first reservoir. Doing so allows for a more compact system in addition to allowing the reservoir with the vent to be in close contact with the reservoir with the fluid.
Regarding claim 9, modified Ramstad teaches all of claim 1 as above but does not teach “wherein the rotationally symmetric container has a cylindrical shape.”.
Boehm teaches “wherein the container has a cylindrical shape.” (Fig. 11, blood collector is cylindrical shape).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ramstad to incorporate the teachings of Boehm the second reservoir is centrally arranged and surrounded by the at least one first reservoir. Doing so allows for a more compact system in addition to improving fluid dynamics.
Claims 5 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Ramstad et. al. (US 20160089668 A1) in view of Beckbissingerde et. al. (DE 102013214859 A1), English translation and Elizarov et. al. (KR 20080044306 A), English translation as applied to claim 1 and in view of Rajagopal et. al. (US 10639628 B2).
Regarding claim 5, modified Ramstad teaches all of claim 1 as above in addition to teaching within (Para [0071], that the reservoir within the cartridge (container) may be configured to facilitate draining liquid by using the outlet port 230 but does not explicitly teach “wherein the inner bottom surface of the rotationally symmetric container is a drain plate comprising a drain”.
Rajagopal teaches a sample detection container with a microcavity which houses a liquid in addition to “wherein the inner bottom surface of the container is a drain plate comprising a drain”. (Fig 1 and Abstract and Column 31 lines 32-36, container 102 which attaches to cap 104. In which as the container is tilted, the liquid (e.g., the supernatant of the sample) drains out of the container through a thin film of liquid that forms along the lower surface of the container).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ramstad to incorporate the teachings of Rajagopal wherein the inner bottom surface of the container is a drain plate comprising a drain. Doing so allows the system to drain unwanted parts within the fluid as taught within Rajagopal.
Regarding claim 10, modified Ramstad teaches all of claim 1 as above but does not teach “wherein the fins of the rotationally symmetric container are arranged directly next to another so that the rotationally symmetric container is surrounded by a ring formed by the fins.”.
Rajagopal teaches “wherein the fins of the container are arranged directly next to another so that the container is surrounded by a ring formed by the fins.”. (Fig 1 and Column 18 lines 42-50, the sample detection container 102 includes an outer surface 122 that includes one or more tracks or threads 123 adjacent the open end 114. Fig. 1 depicts at least 3 threads (fins) directly next to each other (nothing between them) and they are surrounding the ring.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ramstad to incorporate the teachings of Rajagopal the fins of the container are arranged directly next to another so that the container is surrounded by a ring formed by the fins. Doing so allows for multiple fins arranged next to each other which would allow for the two components to be better secured to each other.
Response to Amendments
Claim Amendments
Applicant’s amendments have not overcome the claim objections set forth in the non-final office action. Applicant’s amendments have overcome the 112b rejection for claim 2 but not claim 7.
Response to Arguments
Applicant's arguments filed 1/22/26 have been fully considered.
Applicant's argues that the prior art does not teach (1) a rotationally symmetric container, or (2) a container comprising fins on its outer edge and a dock with corresponding recesses in the dock for accommodating the fins.
Examiner agrees that the prior art in the non-final does not teach to the rotationally symmetric container and has made a new 103 rejections using the rotationally symmetric teachings within Beckbissingerde. Examiner also points out that a cylindrical container, which is well known in the art, is rotationally symmetric. The shape of the container could be optimized using shapes well known in the art such as a cylinder which is rotationally symmetric. Examiner maintains that prior art within the non-final teach to the fins and the recesses within the dock as Elizarov teaches having the fins between the flow device and having them drive the second layer which closes a fluidic channel teaches to the fins joining two components such as (container and dock).
Applicant argues that the reservoir for ventilation is centrally arranged in the container and surrounded by the at least one first reservoir for taking up a fluid, as claimed in Applicant's dependent claim 7. Again, Applicant's review indicates that this structural feature is not taught by either prior art Ramstad or Boehm. Examiner points out that claim 7 does not recite “arranged” and even if it did this claimed feature is taught within Boehm as taught within the rejection using Fig. 4.
Applicant argues that Boehm, it is not clear that central region 408 is, in fact, a reservoir for taking up (i.e., holding) a fluid. Applicant further states that its simply a conduit for fluid among the spokes 412 of the capillary system. The examiner disagrees and points to (Column 10 lines 64-67 to Column 11 lines 1-3, There are five spoke channels 412 which are shown as connecting the central region 408 with the outer channel 410. Where the spoke channels 412 meet the outer channel 410 there are sharp edges 414. These sharp edges and the outer channel 410 form the capillary stop to keep the blood sample within the central region 408 and the spoke channels 412.) Therefore the central region being about t0 keep the blood sample teaches to it being a reservoir and holding a fluid.
Examiner has made new 103 rejections based on claim amendments.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 8:30am – 4:30 pm.
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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.
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/V.E.H./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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