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 .
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.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. A copy of Italian Application IT102020000031580 has been filed with a priority date of 21 December 2020.
Claim Objections
Claim 18 is objected to because of the following informalities: Claim 18 recites “the glass slid” in line 3. It appears the claim limitation should recite “the glass slide” for consistency with the rest of the claims. Appropriate correction is required.
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Regarding claim 5, Wilding discloses the invention of claim 1, however, fails to disclose “[the] cartridge … comprising reference marks configured to identify a height at which the surface is located on which an adhesion phenomenon of the platelets and fibrin will occur” as recited instant claim independent claim 5.
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 10 and 19 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 10 recites the limitation “the fitting” in line 10. There is insufficient antecedent basis for this limitation in the claim. It appears the limitation of the claim should recite “a fitting” for proper antecedent basis.
Claim 19 recites the limitation “the fitting” in line 9. There is insufficient antecedent basis for this limitation in the claim. It appears the limitation of the claim should recite “a fitting” for proper antecedent basis.
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 1-4, 6, 8-11, 13 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Patent Application Publication US 2007/0172389 to Wilding et al. (herein Wilding) as cited on the 06/21/23 IDS.
Regarding claim 1, Wilding discloses appliance 50 (i.e., cartridge) (see [0047]; Fig. 5) suitable for conducting a dynamic ex-vivo evaluation method of the coagulation process of in a subject’s blood sample (see [0075]), comprising flow channel 20 (i.e., at least one perfusion chamber) (see [0075]; Figs. 5-6), inlet port 51 (i.e., well) for loading the blood sample (see [0047]; Fig. 5) and reagents (see [0015]), an inclined ascending microchannel connecting well 51 to a first port 16 (i.e., first end) of the at least one perfusion chamber 20 and an inclined descending microchannel placed at a second port 16 (i.e., second end) of the perfusion chamber (see [0047]; Figs. 5-6). Note: According to the Oxford English Dictionary, inclined means “positioned so as to form an angle with something else”. Therefore, as the claim does not specify a particular angle of incline, the ascending and descending channels forming a 90 degree angle with the at least one perfusion chamber 20A/B reads on the broadest reasonable interpretation of the claim (see Fig. 5).
Regarding claim 2, Wilding discloses the invention of claim 1 and discloses wherein cartridge 50 comprises at least two perfusion chambers 20A/B placed in parallel (see Fig. 6) and wherein at least two of said perfusion chambers have a different width (see [0075]; Table 2).
Regarding claim 3, Wilding discloses the invention of claim 1 and discloses wherein the cartridge 50 comprises a fitting for a syringe pump (see [0077]).
Regarding claim 4, Wilding discloses the invention of claim 1 and discloses wherein the at least one perfusion chamber is closed by a glass cover (i.e., slide), the surface of the glass slide 12 facing the perfusion chamber 20 (see [0045]; Fig. 5) comprising a reactive substance (see [0075]; Example 1). Note: Fig. 5 discloses the glass slide 12 as forming the top of the perfusion chamber 20. Therefore, introducing an antibody (i.e., reactive substance) into the perfusion chamber to dry and coat the channel would include the surface of the glass slide facing the perfusion chamber.
Regarding claim 6, Wilding discloses the invention of claim 1 and discloses wherein the perfusion chamber 20 has an elongated shape and comprises a first end 16 connected to the inclined ascending microchannel (see Fig. 5), the perfusion chamber 20 being divided into two parallel half-chambers represented by 22/24A and 22/24B by a dividing partition (see Fig. 8), the two half-chambers having a different width (see [0043], [0075]). Wilding discloses flow rates can be controlled within the cartridge (see [0064]). As, Wilding discloses all the limitations of claim 6, the invention as disclosed by Wilding would be capable of maintaining a same blood flow rate in the two half-chambers to obtain two different shears.
Regarding claim 8, Wilding discloses the invention of claim 1 and discloses the cartridge 50 comprising a plurality of perfusion chambers 20, wherein the centrally positioned perfusion chamber has a width which is the same or different of one or both of the other perfusion chambers (see Fig. 8). As the width of the centrally positioned perfusion chamber has to either be the same or different from the other perfusion chambers, Fig. 8 reads on the limitation of the claim.
Regarding claim 9, Wilding discloses the invention of claim 8 and discloses wherein the central perfusion chamber and/or one or both of the other perfusion chambers are divided into two half-chambers 22A/B/C and 24A/B/C by a separating partition, represented by the channel in between (see Fig. 8).
Regarding claim 10, Wilding discloses the invention of claim 1 and discloses wherein the perfusion chamber 20 is placed in a transverse position, along an x axis, with respect to a y axis of the cartridge 50 (see Fig. 5), the perfusion chamber 20 being divided into two half-chambers (22/24A, 22/24B, 22/24C) by a dividing partition and wherein a first half-chamber has a width equal to or different from the width of the second half-chamber (as this is the only possibility), wherein the perfusion chamber 20 comprises a first port 16 (i.e., reads on accumulation tank as well as first end) placed upstream of the half-chambers, and a second port 16 (i.e., reads on collection tank as well as second end) placed downstream of the half-chambers, and wherein the inclined ascending micro-channel connects the well 51 with the accumulation tank 16, while the inclined descending micro-channel connects the collection tank 16 with a holder (i.e., fitting) for a syringe (see [0077]).
Regarding claim 11, Wilding discloses the invention of claim 1 and discloses wherein the at least one perfusion chamber is closed by a glass cover (i.e., slide), the surface of the glass slide 12 facing the perfusion chamber 20 (see [0045]; Fig. 5) comprising a reactive substance (see [0075]; Example 1). Note: Fig. 5 discloses the glass slide 12 as forming the top of the perfusion chamber 20. Therefore, introducing an antibody (i.e., reactive substance) into the perfusion chamber to dry and coat the channel would include the surface of the glass slide facing the perfusion chamber. As Wilding fang discloses perfusion chamber 20 can be separated into a plurality of perfusion chambers 22A, 22B, and 22C, each with their own antibody to a particular blood antigen to cause aggregation (see [0079]), Wilding reads on the wherein the glass slide would comprise discrete and predefined portions of the surface of the glass slide facing the perfusion chamber 20 comprising one or more reactive substances or marking compounds (i.e., antibodies) to promote aggregation by a different nature (i.e., blood type A, B, Rhesus antigens) (see [0079]).
Regarding claim 13, Wilding discloses the invention of claim 1 and discloses pairing the cartridge 50 with a syringe pump (see [0076-0080] and wherein the system is disposable (see [0008]). As Wilding discloses all the structural components of the claimed disposable kit, Wilding reads on the disposable kit itself of the claimed invention.
Regarding claim 15, Wilding discloses the invention of claim 1 and discloses wherein the perfusion chamber 20 has an elongated shape and comprises a first end 16, connected to the included ascending microchannel, and a second end 16, connected to the inclined descending microchannel, the perfusion chamber 20 being divided into two parallel half-chambers (22/24A and 22/24B) by a dividing partition, which has, at the first end 16, a wedge profile (the point at which the perfusion chambers divide is wedge shaped), the two half-chambers having a different width (see [0043], [0075]). Wilding discloses flow rates can be controlled within the cartridge (see [0064]). As, Wilding discloses all the limitations of claim 15, the invention as disclosed by Wilding would be capable of maintaining a same blood flow rate in the two half-chambers to obtain two different shears.
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 7, 16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent Application Publication US 2007/0172389 to Wilding et al. (herein Wilding) as cited on the 06/21/23 IDS.
Regarding claim 7, Wilding discloses the invention of claim 1 and discloses wherein the perfusion chamber 20 extends along an axis and has in series along said axis a first half-chamber 22B having a first width and a second half-chamber 24B having a second width (see Fig. 8).
Wilding fails to explicitly disclose “a second width different from the first width”, however, Wilding does disclose that flow channels of varying widths can be fabricated (see [0043]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the width of the second half-chamber to be different from the first half-chamber for the benefit of adjusting the microchannel dimensions depending on cartridge use/application (see [0009]).
Regarding claim 16, Wilding discloses all the limitations of claim 1 above and discloses a syringe pump (see [0076-0080]). As Wilding discloses the cartridge 50 and a syringe pump and wherein the system is disposable (see [0008]).
Wilding fails to disclose “wherein the syringe pump is pre-assembled with the cartridge in a fixed or removable manner” as recited in the instant claim. However, it would have been obvious to one of ordinary skill in the art to pre-assemble the cartridge and syringe pump (i.e., make integral) in a fixed manner as this would be considered an obvious design choice absent any unexpected results (see MPEP2144.03 V. B. Making Integral) or in a removal manner for the benefit of obtaining access to either the end of the syringe pump itself or the inside of the cartridge (see MPEP 2144.03 V. C. Making Separable). As Wilding discloses all the structural components of the claimed disposable kit, Wilding reads on the disposable kit itself of the claimed invention.
Regarding claim 19, Wilding discloses the invention of claim 1 and discloses wherein the perfusion chamber 20 is placed in a transverse position, along an x axis, with respect to a y axis of the cartridge 50 (see Fig. 5), the perfusion chamber 20 being divided into two half-chambers (22/24A, 22/24B, 22/24C) by a dividing partition and wherein a first half-chamber has a width equal to or different from the width of the second half-chamber (as this is the only possibility), wherein the perfusion chamber 20 comprises a first port 16 (i.e., reads on accumulation tank as well as first end) placed upstream of the half-chambers, and a second port 16 (i.e., reads on collection tank as well as second end) placed downstream of the half-chambers, and wherein the inclined ascending micro-channel connects the well 51 with the accumulation tank 16, while the inclined descending micro-channel connects the collection tank 16 with a holder (i.e., fitting) for a syringe (see [0077]).
Wilding fails to explicitly disclose “the accumulation and collection tanks having a greater depth than the half-chambers”, however, Wilding does disclose that components of the cartridge having varying depths can be fabricated (see [0043]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the depth of the accumulation and collection tanks to be greater than the half-chambers for the benefit of adjusting the cartridge dimensions depending on cartridge use/application (see [0009]).
Claims 12 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent Application Publication US 2007/0172389 to Wilding et al. (herein Wilding) as cited on the 06/21/23 IDS in view of United States Publication Application US 2015/0025348 to Grabowski as cited on the 06/21/23 IDS.
Regarding claim 12, Wilding discloses the invention of claim 11, however, fails to disclose “wherein said one or more reactive substances is chosen from type I fibrillar Collagen, type I/III Collagen, type VI Collagen, PG-M/versican (vascular), Perlecan Fibronectin, Laminin-1, Vitronectin, Decorin, Biglycan, Fibulin-1, Tenascin-C, Lumican, Thrombospondin-1, emilin and tissue factor” as recited in the instant claim.
Grabowski discloses devices and methods for assessing coagulation in a channel configured such that shear stress, in a first portion of the channel, applied to blood drawn through the channel by a vacuum-type tube attached to an outlet of the channel approximates physiological shear stress (see abstract). Grabowski discloses the use of controlled microfluidics to observe platelet adhesion/aggregation on a collagen-coated glass cover slip (see [0003]) and quantifying tissue factor positive microparticles on platelets attached to the surfaces of a microchannel (see [0015]). Grabowski discloses wherein the glass slide is functionalized with tissue-factor expressing endothelium (See [0035]).
Grabowski and Wilding are analogous in the field of microfluidic devices for blood aggregation analysis. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the reactive substance of Wilding to be tissue factor in view of Grabowski for the benefit of determining a subject’s clotting risk (see [0003] of Grabowski).
Regarding claim 17, Wilding discloses the invention of claim 1 and discloses wherein the at least one perfusion chamber is closed by a glass cover (i.e., slide), the surface of the glass slide 12 facing the perfusion chamber 20 (see [0045]; Fig. 5) comprising a reactive substance (see [0075]; Example 1). Note: Fig. 5 discloses the glass slide 12 as forming the top of the perfusion chamber 20. Therefore, introducing an antibody (i.e., reactive substance) into the perfusion chamber to dry and coat the channel would include the surface of the glass slide facing the perfusion chamber. As Wilding fang discloses perfusion chamber 20 can be separated into a plurality of perfusion chambers 22A, 22B, and 22C, each with their own antibody to a particular blood antigen to cause aggregation (see [0079]), Wilding reads on the wherein the glass slide would comprise discrete and predefined portions of the surface of the glass slide facing the perfusion chamber 20 comprising one or more reactive substances or marking compounds (i.e., antibodies) to promote aggregation by a different nature (i.e., blood type A, B, Rhesus antigens) (see [0079]).
Wilding fails to disclose “by marking compounds selected from the group consisting of: phosphatidylserine, P-selectin, fibrinogen and derivatives thereof, thrombin, allb33, von Willebrand factor, thrombospondin-1, Factor V, Factor XII, Factor VIII, Factor IX, Factor X, differentiated and undifferentiated dendritic cells, tumor antigens, tumor lysates, leukocytes, immature granulocytes, hematopoietic progenitor cells, erythroblasts, red blood cells, tissue factor and platelet antigens” as recited in the instant claim.
Grabowski discloses devices and methods for assessing coagulation in a channel configured such that shear stress, in a first portion of the channel, applied to blood drawn through the channel by a vacuum-type tube attached to an outlet of the channel approximates physiological shear stress (see abstract). Grabowski discloses the use of controlled microfluidics to observe platelet adhesion/aggregation on a collagen-coated glass cover slip (see [0003]) and quantifying tissue factor positive microparticles on platelets attached to the surfaces of a microchannel (see [0015]). Grabowski discloses wherein the glass slide is functionalized with tissue-factor expressing endothelium (See [0035]).
Grabowski and Wilding are analogous in the field of microfluidic devices for blood aggregation analysis. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the reactive substance of Wilding to be tissue factor in view of Grabowski for the benefit of determining a subject’s clotting risk (see [0003] of Grabowski).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over United States Patent Application Publication US 2007/0172389 to Wilding et al. (herein Wilding) as cited on the 06/21/23 IDS in view of European Patent Publication EP 1636595B1 to Ranby.
Regarding claim 14, Wilding discloses the invention of claim 13, however, fails to disclose “one or more sealed test tubes with reagents” as recited in the instant claim. Wilding is silent to the type of reagent container.
Ranby discloses a test kit for performing blood coagulation analysis comprising a sealed test tube containing reagents (see [0017]).
Ranby and Wilding are analogous in the field of blood analysis. Therefore, it would have been obvious for the kit of Wilding to comprise sealed test tubes with reagents in view of Randy as Randy discloses sealed test tubes are suitable for containing reagents (see MPEP 2144.07 Art Recognized Suitability for an Intended Purpose).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over United States Patent Application Publication US 2007/0172389 to Wilding et al. (herein Wilding) as cited on the 06/21/23 IDS in view of European Patent Publication EP 1636595B1 to Ranby; United States Patent Application Publication US 2016/0334612 to Stoecker et al. (herein Stoecker); and United States Patent Application US 2018/0169657 to Kelly et al. (herein Kelly).
Regarding claim 18, Wilding discloses the limitation of claim 13 above and discloses wherein the at least one perfusion chamber is closed by a glass cover (i.e., slide), the surface of the glass slide 12 facing the perfusion chamber 20 (see [0045]; Fig. 5) comprising a reactive substance (see [0075]; Example 1). Note: Fig. 5 discloses the glass slide 12 as forming the top of the perfusion chamber 20. Therefore, introducing an antibody (i.e., reactive substance) into the perfusion chamber to dry and coat the channel would include the surface of the glass slide facing the perfusion chamber. As Wilding fang discloses perfusion chamber 20 can be separated into a plurality of perfusion chambers 22A, 22B, and 22C, each with their own antibody to a particular blood antigen to cause aggregation (see [0079]), Wilding reads on the wherein the glass slide would comprise discrete and predefined portions of the surface of the glass slide facing the perfusion chamber 20 comprising one or more reactive substances or marking compounds (i.e., antibodies) to promote aggregation by a different nature (i.e., blood type A, B, Rhesus antigens) (see [0079]).
Wilding fails to disclose “one or more sealed test tubes with reagents” as recited in the instant claim.
Ranby discloses a test kit for performing blood coagulation analysis comprising a sealed test tube containing reagents (see [0017]).
Ranby and Wilding are analogous in the field of blood analysis. Therefore, it would have been obvious for the kit of Wilding to comprise sealed test tubes with reagents in view of Randy as Randy discloses sealed test tubes are suitable for containing reagents (see MPEP 2144.07 Art Recognized Suitability for an Intended Purpose).
Wilding fails to disclose “one or more glass slides … comprising two or more reference marks comprising engravings” as recited in the instant claim.
Stoecker discloses transparent object carrier (i.e., glass slide) with impressed markings (i.e., reference marks comprising engravings) (see abstract).
Stoecker and Wilding are analogous in the field of using glass slides for biological sample analysis. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the glass slide of Wilding to comprise the engraved reference marks of Stoecker for the benefit of dividing the glass slide into a plurality of sections (see abstract).
Finally, Wilding fails to disclose “wherein the one or more glass slides comprise, on the surface treated with the reactive substance, a removable protective film or a protective film already coupled with the cartridge” as recite in the instant claim.
Kelly discloses a cartridge 200 comprising a functionalized glass substrate 202 and a sealing membrane 206 (i.e., protective film) overlying said glass substrate (see [0120-0124]).
Kelly and Wilding are analogous in the field of using devices for blood analysis. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to add the protective film of Kelly to the cartridge of Wilding for the benefit of protecting cartridge contents from, for example, evaporation (see [0022] of Kelly).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHRYN E LIMBAUGH whose telephone number is (571)272-0787. The examiner can normally be reached Monday-Thursday 7:00-5:00.
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/KATHRYN ELIZABETH LIMBAUGH/Primary Examiner, Art Unit 1797