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
Claims 12-13 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 12 recites the limitation "the honeycomb structure" in line 1. There is insufficient antecedent basis for this limitation in the claim, as claim 12 depends directly from claim 1 and the honeycomb structure is introduced in claim 11. It is recommended that the dependency of claim 12 be amended such that claim 12 depends from claim 11 instead to provide antecedent basis to this feature. Examination will continue under the assumption that claim 12 is intended to depend from claim 11.
Claim 13 depends from claim 12 and is also rejected for inheriting the deficiency as noted above.
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, 4, and 7-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sorenson et al. (US Patent No. 4,006,745).
With respect to claim 1, Sorenson et al. discloses a thrombus removal system (see Fig. 1, col. 3, lines 62-64: “Filter screen 44 assists in removing entrained air in the blood and in separating out tissue fragments and the like aspirated with the blood”), comprising:
an elongate shaft (24 in Fig. 1);
an aspiration lumen extending along the elongate shaft (col. 3, lines 26-29: “The first receptacle 30 is evacuated through the vacuum line 34 so as to create a suction in the aspiration wand 24 and tube 26. Thus, blood is aspirated at the wand 24 and deposited in the first receptacle 30”);
a vacuum source (34) fluidly coupled to the aspiration lumen (lumen of 24, see col. 3, lines 26-29 as cited above);
a thrombus filter (44 in Figs. 2-3) disposed along the aspiration lumen (see Figs. 1-2, the aspiration connects at 28, filter 44 is disposed along the aspiration lumen of wand 24); and
a blood collection cannister (30 and 36) disposed proximally from the thrombus filter (44, part of 03 is disposed proximally from filter 44) along the aspiration lumen (lumen of 24, see Fig. 1), the blood collection cannister (30 and 36) including a moveable separator (valve 50 and liner 52) that divides the blood collection cannister (30 and 36) into first and second chambers (30 and 36 are first and second chambers, respectively), wherein operation of the vacuum source causes clot removed from the patient to collect on the thrombus filter (col. 3, lines 59-64: “Filter screen 44 is placed in the blood receiving chamber or receptacle 30 so as to transect receptacle 30 and thereby serve as a filter screen for all blood entering receptacle 30. Filter screen 44 assists in removing entrained air in the blood and in separating out tissue fragments and the like aspirated with the blood”) and blood removed from the patient to collect in the first chamber (see blood collecting in bottom 46 of first chamber 30 between Figs. 1-2).
Regarding claim 2, Sorenson et al. further discloses wherein operation of the vacuum source further causes saline to flow into the second chamber and a vacuum cannister (col. 8, lines 30-35: “Prior to actual infusion of the blood into the patient, air may be expelled from the blood delivery system either with isotonic saline, blood or other suitable injectable solution. The flexible liner 52 is filled as the second receptacle 36 is evacuated as represented by arrow 110 (FIG. 2) and emptied when the second receptacle 36 is pressurized as represented by arrow 114 (FIG. 3)”).
Regarding claim 4, Sorenson et al. further discloses wherein the thrombus filter (44 in Figs. 2-3) is configured to allow blood to pass but not allow thrombus to pass (col. 3, lines 62-64: “Filter screen 44 assists in removing entrained air in the blood and in separating out tissue fragments and the like aspirated with the blood”).
Regarding claim 7, Sorenson et al. further discloses wherein the separator (valve 50 and liner 52 in Figs. 2-3) comprises a diaphragm (liner 52 is a diaphragm as it is a flexible compartment configured to be pressurized).
Regarding claim 8, Sorenson et al. further discloses at least one saline source fluidly coupled to the second chamber (36 in Figs. 2-3, col. 8, lines 30-35: “Prior to actual infusion of the blood into the patient, air may be expelled from the blood delivery system either with isotonic saline, blood or other suitable injectable solution. The flexible liner 52 is filled as the second receptacle 36 is evacuated as represented by arrow 110 (FIG. 2) and emptied when the second receptacle 36 is pressurized as represented by arrow 114 (FIG. 3)”).
Regarding claim 9, Sorenson et al. further discloses wherein the at least one saline source is removable from the blood collection cannister (30 and 36 in Figs. 1-2, 36 in Figs. 2-3, col. 8, lines 30-35: “Prior to actual infusion of the blood into the patient, air may be expelled from the blood delivery system either with isotonic saline, blood or other suitable injectable solution. The flexible liner 52 is filled as the second receptacle 36 is evacuated as represented by arrow 110 (FIG. 2) and emptied when the second receptacle 36 is pressurized as represented by arrow 114 (FIG. 3)”, saline is added via arrow 114 by a removable saline source).
Regarding claim 10, Sorenson et al. further discloses a blood return line (39 in Fig. 4, see also Fig. 8) fluidly coupled to the first chamber (30).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Sorenson et al. (US Patent No. 4,006,745) as applied to claim 1 above, and further in view of Barnes et al. (US Patent No. 4,954,251).
Regarding claim 3, Sorenson et al. is silent on wherein the filter has a pore size of up to 40 microns.
In the same field of blood filtering (abstract), Barnes et al. teaches a microaggregate blood filter (see Fig. 3) comprising mesh filter elements including a pore size of up to 40 microns (claim 1: “the outer filter screen having an average pore size of about 40 microns and being adapted to hold back blood microaggregates larger than about 40 microns”).
It would have been prima facie obvious for one of ordinary skill in the art to have modified the Sorenson et al. device according to the Barnes et al. teachings to yield a filter having a pore size of up to 40 microns, as the present disclosure places no criticality on the claimed range, stating only that the filter “may have a 40-micron pore size corresponding to many conventional or traditional filters for red blood cells” (PP [0123]), and furthermore since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists” (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Sorenson et al. (US Patent No. 4,006,745), as applied to claim 1 above, and further in view of Laster (US PGPub 2014/0358060 A1).
Regarding claim 5, Sorenson et al. fails to disclose wherein the thrombus filter is positively charged.
In the same field of filtering blood (abstract), Laster teaches a system including a filter (30 in Fig. 3) and an electrical system configured to apply a positive charge to the filter (30, see PP [0102]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Sorenson et al. device to include applying a positive charge to the filter. One of ordinary skill in the art would have been motivated to perform this modification in order to “keep the membrane clean” to prevent the filter from clogging (PP [0102]). The modification as proposed would not alter the main operating principle of the Sorenson et al. device, which already contemplates optional ways to avoid clogging the filter screen (see angular orientation of 44 in Fig. 2, see also last paragraph of col. 3 which states that the angular orientation is preferable but not required), but would simply and predictably provide an alternate avenue for ensuring that the screen remains clear throughout the procedure.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Sorenson et al. (US Patent No. 4,006,745), as applied to claim 1 above, and further in view of Sukavaneshvar et al. (US PGPub 2007/0037132 A1).
Regarding claim 6, Sorenson et al. discloses wherein positive and negative pressure is selectively applied between the second chamber (36 in Figs. 2-3) and the separator (which includes liner 52) in order to control the separation and transfer of the patient’s blood (see col. 5, lines 3-19: “In the operation of the embodiment of FIGS. 2 and 3, the valve 88 (FIG. 1) is situated so as to evacuate (as represented by arrow 110, FIG. 2) the space between the liner 52 and the receptacle 36. This reduced pressure expands liner 52 and unidirectionally transfers blood from receptacle 30 through the valve 50 into the liner 52. Thereafter, valve 58 is opened and valve 88 switched to pressure as represented by arrow 114 (FIG. 3). The elevated pressure source may be conventional pressurized gas available in most operating and emergency rooms. A conventional hand operated squeeze bulb could also be used to selectively develop elevated pressure at the port 60. Positive pressure thus created will develop between the liner 52 and the second receptacle 36 to force blood from liner 52 into the transfer bag 38. Retrograde flow from liner 52 into the first receptacle 30 is prevented by the one-way valve 50”) but fails to disclose wherein the separator comprises a plunger.
In the same field of filtering blood (abstract), Sukavaneshvar et al. teaches a blood filter (24 in Fig. 3) including a separator (see valve 30 and syringe 44), wherein the separator comprises a plunger (syringe 44 has a plunger, see PP [0034]) for creating negative pressure.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Sorenson et al. device according to the teachings of Sukavaneshvar et al. to include a syringe plunger in the separator. One of ordinary skill in the art would have been motivated to perform this modification as it is a simple substitution of pressurizing devices that would have yielded predictable results, as Sorenson et al. already contemplates a hand operated squeeze bulb or conventional pressurized gas. Sukavaneshvar et al. demonstrates that the syringe plunger as taught is capable of selectively creating positive and negative pressure environments as required for operation of the blood filter such that the modification as proposed would not alter the main operating principle of the Sorenson et al. device.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Sorenson et al. (US Patent No. 4,006,745), as applied to claim 1 above, and further in view of Bachmann et al. (US PGPub 2014/0377738 A1).
Regarding claim 11, Sorenson et al. fails to disclose wherein the thrombus filter comprises a honeycomb structure.
In the same field of blood filtering (abstract), Bachmann et al. teaches a blood filter (102 and 104 in Fig. 2) for filtering particulates from blood, wherein the filter comprises a honeycomb structure (PP [0028]: “first filter 102 and/or second filter 104 may be a sheet of graphene including a plurality of apertures, e.g., a perforated graphene sheet. Graphene is a single-atomic-layer-thick layer of carbon atoms which may form a sheet. The carbon atoms of a graphene sheet define a repeating pattern of hexagonal ring structures (benzene rings) constructed of six carbon atoms, which form a honeycomb lattice of carbon atoms. An interstitial aperture is formed by each six carbon atom ring structure in the sheet and this interstitial aperture is much less than one nanometer across and is much too small to allow the passage of water or other blood constituents”, see also honeycomb in Figs. 3-4, PP [0008]: “an apparatus configured to isolate a substance from blood, wherein particles of the substance have an effective diameter that is within a range defined by effective diameters of constituents of blood, comprises means for regulating the flow of the blood through a first sheet of graphene including a first plurality of apertures, wherein the first plurality of apertures are configured to pass objects with an effective diameter less than or equal to the effective diameter of the particles of the substance”).
It would have been prima facie obvious for one of ordinary skill in the art to have modified the Sorenson et al. device to specifically include the honeycomb filter structure as taught by the Bachmann et al. reference. One of ordinary skill in the art would have been motivated to perform this modification as it is a combination of prior art elements according to known methods to yield predictable results, as the honeycomb filter of Bachmann et al. would predictably be configured to filter out particulates of varying sizes, including thrombus, to fulfill the main operating principle of the Sorenson et al. device. Modifying the filter of Sorenson et al. to include the honeycomb structure of Bachmann et al. would have therefore been a predictable combination, since both filters are adapted to filter particles from blood and merely perform the same function when combined as they do separately.
Regarding claim 12, Sorenson et al. as modified by Bachmann et al. further discloses wherein the honeycomb structure (PP [0028] of Bachmann et al. as cited above for claim 11) comprises a plurality of openings interspersed between closed sections (PP [0008]: “an apparatus configured to isolate a substance from blood, wherein particles of the substance have an effective diameter that is within a range defined by effective diameters of constituents of blood, comprises means for regulating the flow of the blood through a first sheet of graphene including a first plurality of apertures, wherein the first plurality of apertures are configured to pass objects with an effective diameter less than or equal to the effective diameter of the particles of the substance”).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Sorenson et al. (US Patent No. 4,006,745) in view of Bachmann et al. (US PGPub 2014/0377738 A1), as applied to claims 11-12, and further in view of Laster (US PGPub 2014/0358060 A1).
Regarding claim 13, Sorenson et al. as modified by Bachmann et al. fails to disclose an electrical system configured to apply a positive charge to the closed sections.
In the same field of filtering blood (abstract), Laster teaches a system including a filter (30 in Fig. 3) and an electrical system configured to apply a positive charge to the filter (30, see PP [0102]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination as proposed to include applying a positive charge to the filter. One of ordinary skill in the art would have been motivated to perform this modification in order to “keep the membrane clean” to prevent the filter from clogging (PP [0102]). The modification as proposed would not alter the main operating principle of the Sorenson et al. device, which already contemplates optional ways to avoid clogging the filter screen (see angular orientation of 44 in Fig. 2, see also last paragraph of col. 3 which states that the angular orientation is preferable but not required), but would simply and predictably provide an alternate avenue for ensuring that the screen remains clear throughout the procedure.
Conclusion
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771
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