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 Interpretation
Independent system claims 1 and 3, recite structural limitations followed by the manner to operate said limitations with corresponding functional language, or language regarding intended system use concerning the outlet being a vessel which is alternatively configured to be in fluidic connection with a vessel (“the outlet…and/or is configured to be in fluidic connection with a vessel”).
The claim clause “outlet…configured to be in fluidic connection with a vessel” is deemed to not introduce or correspond to any additional structural limitation regarding the recited outlet of the support structure having any additional component or feature, thus Independent claims 1 and 3, as well as claims dependent therefrom are interpreted as including the structural features claimed otherwise but not requiring the actual presence of a vessel.
It is noted that neither the manner of operating an apparatus worded as a disclosed device (or “system”), nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2114 and 2115. See Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App & Inter. 1987) that states a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim.”
Additionally in claim 1, the respective recited configuration positions of the absorbent layer and compression device are interpreted as positively reciting such respective positions with the ambiguous claim language of “can be positioned…” (2 occurrences), the claim is thus interpreted as being intended to recite such configuration positions as actually being present.
Similarly, in claim 3, the recited configuration position of the absorbent layer and is interpreted as positively reciting such position with the ambiguous claim language of “can be positioned…”, the claim is thus interpreted as being intended to recite such configuration position as actually being present.
In claim 5, “with reduced number of red blood cells…” although ambiguous, is interpreted as meant to be referring to the number of red blood cells, in a given volume of blood, i.e. “concentration of red blood cells in blood after passage through the separation device having been “reduced” from such value before passage through the separation device.
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 1,5,16-20,22-30,36,38 and 41 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
In claim 1, “can be positioned…” (2 occurrences) is ambiguous and indefinite as to whether the respective positions of the absorbent layer and compression device are positively recited, required limitations of the claim.
In claim 3, “can be positioned…” is ambiguous and indefinite as to whether the position of the absorbent layer is a positively recited, required limitation of the claim.
In claim 5, “with reduced number of red blood cells…” is ambiguous as to what starting amount of red blood cells is being compared to by “reduced” (number of red blood cells prior them being passed through the separation layer or contacting the absorbent layer?) ;
and it is unclear whether “after the separation device has been removed from the support structure” is positively reciting a method step of such removing.
In claim 20, recitation of “compression device is not removable from the support structure after it is compressed against the absorbent layer” is improperly reciting a method step of ‘compressing’ in the apparatus claim, thus, it is unclear what additional structural feature of the kit apparatus is being claimed.
In claim 24, it is unclear whether “using adhesive” is positively reciting “adhesive” being a claimed component of the kit or instead is improperly reciting a method step of ‘using’ in the kit apparatus claim.
In claim 26, it is unclear whether “when the compression device is placed at the inlet of the support structure” is positively reciting such “placement” being a claimed structural feature of the kit or instead is improperly reciting a method step of ‘placement’ in the kit apparatus claim.
In claim 38, it is unclear whether “absorbent layer is configured to absorb blood plasma” is positively reciting a discrete feature of the absorbent layer.
In claim 41, “absorbent layer has a release” is ambiguous as to what material(s) are released and under what feature(s) or property(ies) of the absorbent layer are being claimed.
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.
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.
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 1, 3, 16-20, 22, 36, 38 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Rostaing et al PGPUBS Document US 2010/0324449 (Rostaing).
Referenced paragraph numbers of the Descriptions of the applied PGPUBS Documents are identified with “[ ]” symbols.
For independent claims 1 and 3, and claims dependent therefrom, Rostaing discloses: a kit (compact device which is transportable between care centers and patient’s homes, [0002, 0004, 0006, 0016-0017] comprising:
a support structure (housing 15 illustrated in figures 1 and 2, and described in [0029, 0035 and 0081] such housing tightly enclosing the disclosed components described below and thus being a “support structure”),
such housing support structure comprising inlets (needle openings of needles 1, as shown in figures 1 and 2, and described at [0082]),
outlets (array 60 of pillars 61 for collecting filtered or separated blood passing through the housing as shown in figures 1 and 2, and described at [0111-0113]), and
a channel communicated with the inlet, (see figure 2 illustrating a channel 14 for directing flow towards chamber or cavity 14, as described at [0074] defined by side walls of housing 15 and being between the inlet and such outlet); and further discloses:
a separation device (filter membrane 2, optionally coupled with a prefilter 6 for filtering blood introduced into the kit or device, figures 1 and 2, [0070, 0074, 0079]); and,
an absorbent layer (adsorbent medium layer 3, figures 1 and 2, [0078]) and,
wherein the absorbent layer and support structure are configured such that the absorbent layer can be positioned in the support structure and be in fluidic connection with the inlet and the outlet of the support structure (evident from figures 1 and 2 and [0029, 0081] ;
wherein the separation device is removable from the support structure [0108 re membrane and prefilter being removed at the end of sample-taking];
and suggests wherein the outlet is a vessel and/or is configured to be in fluidic connection with a vessel [0019 re the blood collection device optionally being incorporated into a diagnosis device, thus outlets being in fluid communication with such device, i.e. suggesting a vessel]; and
for claim 1, also discloses the device or kit comprising a compression device ([0024 re the absorbent optionally being compressed], [0056-0057 re the filter including main filter 2 and prefilter 6 being preferably compressed against means the means that absorb plasma], and [0066 and 0106 re adhesive paper 15 compressing filter portion 2 against absorbent means 3]) and discloses wherein the compression device and support structure are configured such that a portion of the compression device can be positioned “at” the inlet (figures 2 and 6 illustrating such compression device in the form of adhesive paper 15 surrounding inlet means 14/60/61, thus being “at the inlet”); and,
Claims 1 and 3 respectfully differ from Rostaing by explicitly requiring wherein the outlet is a vessel and/or is configured to be in fluidic connection with a vessel.
However, Rostaing at [0019] discloses the blood collection device optionally being incorporated into a diagnosis device.
It is considered that such diagnosis device would inherently include one or more vessels for storing and analyzing collected blood, to provide support for and enable handling and transporting of analytical means, and thus that it would have been obvious to one of ordinary skill in the art of designing or manufacturing kits for separating components of blood or plasma samples,
to have modified the Rostaing kit or device by configuring the disclosed support structure outlet to be communicating with such vessel, so as enable flow of collected, separated blood or plasma component from treatment by separation device and adsorbent layer to a vessel supporting and housing analyzing means in the diagnosis device, without requiring physical, handling and transporting of such blood or plasma component, and to have enabled support for and enable handling and transporting of analytical means.
Rostaing further discloses or suggests the following:
for claim 16, wherein the absorbent layer has an absorbency of greater than or equal to 80 microliters/cm² and less than or equal to 600 microliters/cm² ([0063 suggesting filtered, adsorbed and then collected and stored blood plasma having an accurately calibrated volume, thus the absorbent layer having a selected absorbency],
such absorbency constituting a results-effective parameter range for which it would have been obvious for one of ordinary skill in the prior art to have optimized by routine experimentation, so as to enable collection of the desired accurately calibrated volume. The MPEP, Section 2144.05 includes court rulings that have determined that such types of parameter values or ranges do not support the patentability of such subject matter, particularly where the prior art contains similar ranges, amounts or proportions, or suggests such similarity, absent a finding of unexpected criticality or achieving of unexpected results, the wide range of the recited parameter also suggesting a lack of criticality regarding the recited parameter);
for claim 17, wherein the separation device comprises a first layer and a second layer (figures 8, 9a and b and 12a illustrating layers 2 and 6 of pre-filter and membrane filter, respectfully, as described at [0105-0106]);
for claim 18, wherein the channel of the support structure has an internal volume of less than or equal to 10 milliliters [0061 re “prefilling an empty space corresponding to the volume of blood that is to be treated (10 .mu.l to 150 .mu.L”];
for claim 19, wherein the compression device is removable from the support structure [0106-0108 re assembly including compressing adhesive being removed together];
for claim 20, wherein the compression device is not removable from the support structure after it is compressed against the absorbent layer [0105 re assembly including compressing adhesive being adhesively bonded to a protective film and to the top of the device or kit];
for claim 22, wherein the absorbent layer is secured to the support structure using adhesive [0105-0106 re assembly including compressing adhesive being adhesively bonded to a protective film and to the top of the device or kit]; and,
for claim 36, wherein the absorbent layer is porous [0022 re the absorbent layer being of paper and thus porous];
for claim 38, wherein the absorbent layer is configured to absorb blood plasma [0049 re absorption means for absorbing plasma without denaturing proteins]; and,
for claim 41, wherein the absorbent layer has a release of greater than or equal to 35% [0049-00050 re the plasma which has been adsorbed being later analyzed by mass spectrometry, hence inherently being substantially or fully released so as to be directed to the spectrometry equipment].
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Rostaing et al PGPUBS Document US 2010/0324449 (Rostaing), as applied to claims 1, 3, 16-20, 22, 36, 38 and 41 above, and further in view of Knight et al patent 5,830,359 (Knight).
Referenced paragraph numbers of the Descriptions of the applied PGPUBS Documents are identified with “[ ]” symbols.
For claim 23, Rostaing further discloses wherein the absorbent layer is secured to the support structure [0105-0106 re assembly including compressing adhesive being adhesively bonded to a protective film and to the top of the device or kit housing, which also functions to support all components therein] and (see housing 15 illustrated in figures 1 and 2, and described in [0029, 0035 and 0081] such housing tightly enclosing the disclosed components described below and thus being a “support structure”)].
Claim 23 further differs by requiring such securing to be due to positioning of absorbent layer between ridges in the support structure.
Knight teaches filtering of blood platelets by a filter medium using a filter and absorbing medium (Abstract, column 1, lines 7-14) and teaches securing of components including a filter, to an outer enclosure, or tube, by screw threads, i.e. including oppositely directed consecutive ridges for supporting the components to the outer enclosure, inherently providing a secure support for the components (column 10, lines 16-25).
It would have been further obvious to the skilled artisan to have modified the Rostaing device, by securing filter and adjacent absorbent material to the supporting housing, as taught by Knight, to more securely support the filter and absorbent layer of the kit to the housing, hence prevent movement of components out of position.
Allowable Subject Matter
Claim 5 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) set forth in this Office action.
Claim 5 would distinguish and be non-obvious in view of recitation of “ A method, comprising:
in a support structure comprising an inlet, an outlet, a channel between the inlet and the outlet, a separation device positioned in the support structure, and an absorbent layer positioned in the support structure, performing the steps of
passing a blood sample across the separation device to the absorbent layer, such that a blood sample with reduced number of red blood cells is collected inside the absorbent layer; and
removing the separation device from the support structure after the blood sample with reduced number of red blood cells has been passed into the absorbent layer, all of which is disclosed or taught by the closest prior art deemed as Rostaing et al PGPUBS Document US 2010/0324449 (Rostaing), in view of further recitation of:
“compressing a compression device against the absorbent layer after the separation device has been removed from the support structure”.
Rostaing discloses the following limitations of claim 5: A method, comprising:
in a support structure comprising an inlet, an outlet, a channel between the inlet and the outlet, a separation device positioned in the support structure, and an absorbent layer positioned in the support structure (housing 15 illustrated in figures 1 and 2, and described in [0029, 0035 and 0081] such housing tightly enclosing the disclosed components described below and thus being a “support structure”,
such housing support structure comprising inlets (needle openings of needles 1, as shown in figures 1 and 2, and described at [0082]),
outlets (array 60 of pillars 61 for collecting filtered or separated blood passing through the housing as shown in figures 1 and 2, and described at [0111-0113]), and
a channel communicated with the inlet, (see figure 2 illustrating a channel 14 for directing flow towards chamber or cavity 14, as described at [0074] defined by side walls of housing 15 and being between the inlet and such outlet); and further discloses:
a separation device (filter membrane 2, optionally coupled with a prefilter 6 for filtering blood introduced into the kit or device, figures 1 and 2, [0070, 0074, 0079]), performing the steps of:
passing a blood sample across the separation device to the absorbent layer, such that a blood sample with reduced number of red blood cells is collected inside the absorbent layer [0055-0056 re taking blood from a patient’s finger, i.e., sampling, and filtering and pre-filtering red blood cell corpuscles [0055-0056] ; and
removing the separation device from the support structure after the blood sample with reduced number of red blood cells has been passed into the absorbent layer [0108 re membrane and prefilter being removed at the end of sample-taking], as well as
compressing a compression device against the absorbent layer [0057].
However, Rostaing lacks a teaching or suggestion of “compressing a compression device against the absorbent layer after the separation device has been removed from the support structure”. None of the other cited prior art teaches or suggests such method step.
Claims 24-30 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b), set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 24 would distinguish and be non-obvious over all of the prior art in view of recitation of wherein the compression device comprises a cap.
Rosaing teaches away from such combination of features, by requiring the compression device to be in the form of an adhesive member such as adhesive paper (figures 2 and 6 illustrating such compression device in the form of adhesive paper 15 surrounding inlet means 14/60/61, thus being “at the inlet”, and see [0066 and 0106 re adhesive paper 15 compressing filter portion 2 against absorbent means 3], thus not suggesting a compression means in the form of a cap). None of the other cited prior art suggests such particular feature.
Claim 25 would distinguish and be non-obvious in view of its dependence on claim 24.
Claim 26, would distinguish and be non-obvious over all of the prior art in view of recitation of wherein the compression device comprises a plunger that is configured to compress the absorbent layer when the compression device is placed at the inlet of the support structure.
Again, Rosaing teaches away from such combination of features, by requiring the compression device to be in the form of an adhesive member such as adhesive paper (figures 2 and 6 illustrating such compression device in the form of adhesive paper 15 surrounding inlet means 14/60/61, thus being “at the inlet”, and see [0066 and 0106 re adhesive paper 15 compressing filter portion 2 against absorbent means 3], thus not suggesting a movable compression means such as a plunger). None of the other cited prior art suggests such particular feature.
Claim 27 would distinguish and be non-obvious over all of the prior art wherein the inlet and/or channel of the support structure comprises an interior surface and an exterior surface and further is requiring wherein the exterior surface comprises one or more ridges.
Rosaing teaches away from such combination of features, by either requiring the support to be in the form of the housing, in which case, such outer surface is not attached or secured to any other component by way of such means as screw threading ridges, or alternatively comprises a bent strip 15 (figures 11-13b), in a configuration that lacks any suggestion of screw threading.
Knight which teaches screw threading ridges as discussed with respect to claim 23, lacks a teaching of an outer surface of a support structure having an outer surface with screw threading ridges. None of the other cited prior art suggests such particular feature. None of the other cited prior art suggests such particular feature.
Claims 28 and 30 would also distinguish and be non-obvious by way of its dependence on claim 27.
Claim 29 would distinguish and be non-obvious in view of respective recitations of wherein the compression device is configured to screw onto the support structure.
Rosaing teaches away from such combination of features, by either requiring the support to be in the form of the housing, in which case, such outer surface is not attached or secured to any other component by way of such means as screw threading ridges, or alternatively comprises a bent strip 15 (figures 11-13b), in a configuration that lacks any suggestion of screw threading.
Knight which teaches screw threading ridges as discussed with respect to claim 23, lacks a teaching of an outer surface of a support structure having an outer surface with screw threading ridges. None of the other cited prior art suggests such particular feature.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Of particular interest , McNeely et al PGPUBS Document US 2020/0398225 teaches a system including a filtration membrane and absorbent separation, with a compressing, pressing member adjacent the membrane and absorbent; and Kushon et al PGPUBS Document US 2017/0128934 teaches a plasma extraction system having an absorbent reservoir [0159, 0170], concerning separation of red blood cells from plasma [0170], and teaching a separator relative to adsorbent [0167], and support structure [0140].
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JWD
10/11/2026
/JOSEPH W DRODGE/ Primary Examiner, Art Unit 1773
