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 Status
Rejected Claims: 1, 12, 17, 19, 22-23, 25-26, 30-33, 35, 37, 40, 42, 46, 48, and 50
Cancelled Claims: 2-11, 13-16, 18, 20-21, 24, 27-29, 34, 36, 38-39, 41, 43-45, 47, 49, and 51-88
Response to Amendment
The amendment filed on 04 MARCH 2026 has been entered.
In view of the amendment to the claims, the amendment of claim 1 and the cancellation of claim 2 have been acknowledged.
In view of the amendment to the specification, the objections to the specification have been withdrawn.
In view of the amendment to claim 1, the rejection under 35 U.S.C. 103 has been updated to include the amended limitations and where these are taught in the currently cited prior art.
Response to Arguments
Applicant’s arguments filed on 04 MARCH 2026 have been fully considered.
Applicant argues, regarding instant claim 1, that the rejection includes a cherry-picking of elements with Ray teaching the general three-layer device and Tan, Murray, and Allen to teach different features of each layer which would require impermissible hindsight and so instant claim 1 is allowable (Arguments filed 04 MARCH 2026, Page 16, Paragraphs 1-2).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this case, Ray teaches the general device but lacks some of the specific material properties listed in instant claim 1. Tan, Murray, and Allen are used to demonstrate that these layer properties are well known and optimized in the art with reasons for the modifications listed in the rejections below. Therefore instant claim 1 is not allowable.
Applicant argues, regarding instant claim 1, that Ray does not teach the correct pore size of the first layer and Tan teaches multiple upper layers made of the glass fibers with only one being in the range. Therefore, the combination requires impermissible hindsight and instant claim 1 is allowable (Arguments filed 04 MARCH 2026, Page 16, Paragraph 3 to Page 17, Paragraph 1).
Regarding Applicant’s argument, Ray teaches a multi-component layer 1 involving glass fibers and polyester (Col. 18, Lines 3-27) and Tan teaches a multistage filter system with glass fibers and polyester track etched membranes (Paragraphs 0035-0036). These are similar features located as the first step of whole blood separation devices and it would be obvious to one of ordinary skill in the art to use the pore sizes designated by Tan when selecting the same materials for the filtration stage, or separation layer, as taught by Ray. Therefore, instant claim 1 is not allowable.
Applicant argues, regarding instant claim 1, that Allen discloses a derived absorbency which would fall short of the limitation of instant claim 1 of “a third layer that has an absorbency of greater than or equal to 80 microliters/cm2 and less than or equal to 600 microliters/cm2” because the surface area range of 5-50 mm2 and volume capacity range 1-30 should compared at highest and lowest ranges, with the greatest absorbency being only 60 µL. Applicant further asserts that the cellulosic materials have an absorbency of 60 µL and so this reinforces the idea that the 60 µL is a maximum absorbency of the materials. Therefore, Allen does not disclose an overlapping range and instant claim 1 is allowable (Arguments filed 04 MARCH 2026, Page 17, Paragraph 2 to Page 19, Paragraph 2).
Regarding Applicant’s argument, Allen teaches a pad for receiving fluid from a second membrane that has a surface area of 5 to 50 mm2 and a volume capacity of 1 to 30 µL, which converts to an absorbency range of 2-600 µL/cm2, and further teaches that the thickness of the material can be in a range of 0.1 to 2 mm (Col. 4, Lines 3-20). The thickness of the material is not taken into account via the claim limitation and greater thickness would result in greater absorbency per unit area. Therefore, even if the range of absorbency is not fully 2-600 µL/cm2, the range lies somewhere between these values and still overlaps the range of instant claim 1. Applicant asserts that cellulosic materials have an absorbency of 60 µL/cm2, but provides no source. Cotton, made primarily of cellulose and used commonly for absorbent pads, has a density of 1.52 g/cm3 and is capable of absorbing 27 times its weight in water (Cotton Counts, Cotton and the Consumer, https://www.cotton.org/pubs/cottoncounts/upload/Cotton-and-the-Consumer.pdf, accessed via Wayback Machine on 28 FEBRUARY 2006). Therefore, it is reasonable that the range of absorbency of a cellulose based absorbent pad made obvious by Ray in view of Tan in view of Murray in view of Allen makes obvious the absorbency of instant claim 1 and instant claim 1 is not allowable.
Applicant argues that instant claim 1 is allowable and so the dependent claims are also allowable (Arguments filed 04 MARCH 2026, Page 19, Paragraph 2).
Regarding Applicant’s argument, instant claim 1 is not allowable and so the dependent claims are also not allowable.
Applicant argues that the cited references do not include the newly added limitation to instant claim 1 of wherein the first layer comprises polyester and/or the third layer comprises rayon and so claim 1 is now allowable (Arguments filed 04 MARCH 2026, Page 19, Paragraph 3 to Page 20).
Regarding Applicant’s argument, Ray teaches wherein the separation layer can be comprised of a sandwich of glass fiber material and a polyester track-etched membrane (i.e., wherein the first layer comprises polyester; Col. 18, Lines 3-27) and so claim 1 is not allowable.
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, 12, 17, 19, 22-23, 25-26, 30-33, 35, 37, 40, 42, 46, 48, and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Ray et al US Patent No. 6258045 B1 (hereinafter Ray) in view of Tan et al US Patent Application No. 20170354361 A1 (hereinafter Tan) in view of Murray et al US Patent Application No. 20190391130 A1 (hereinafter Murray) in view of Allen et al US Patent No. 4987085 A (hereinafter Allen).
Regarding Claim 1, Ray teaches the basic construction of the article of claim 1. Tan, Murray, and Allen teach optimizations of different layers of blood separation devices, with all prior art references teaching multi-layered blood separation devices.
Ray teaches a trilaminate configuration (i.e., wherein the second layer is positioned between the first layer and the third layer; Fig. 4A, #90) for the separation of blood and other biological samples comprising a separation layer (i.e., a first porous layer; Fig. 4A, #91) that is composed of glass fibers or nylon (Col. 12, Lines 12-15), a quantitation member (i.e., a second porous layer; Fig. 4A, #94) that may be composed of multiple layers including nylon (i.e., a second layer having a first surface and a second surface; Col. 5, Lines 17-30), and a collection member (i.e., a third layer; Fig. 4A, #97) that is composed of polyester (Col. 18, Lines 47-67) where the collection member can be an absorbent material (i.e., wherein the third layer is porous; Col. 14, Lines 21-37) and wherein the separation layer can be comprised of a sandwich of glass fiber material and a polyester track-etched membrane (i.e., wherein the first layer comprises polyester; Col. 18, Lines 3-27).
Ray further teaches, in another embodiment, that the collection member can be a quantitative collection member that absorbs a constant amount of sample for the purpose of preventing sample overloading from having deleterious effects on analyte concentration determination (Col. 19, Lines 24-60).
Ray does not teach that the first layer has a first mode pore size that is greater than or equal to 1 micron and less than or equal to 30 microns.
However, Tan teaches an upper filter stage made of glass fibers with a pore size of 10-20 µm for the purpose of removing a portion of blood cells (i.e., the first layer has a first mode pore size that is greater than or equal to 1 micron and less than or equal to 30 microns; Paragraph 0035).
Tan is analogous to the claimed invention because it pertains to devices for the separation of whole blood (Abstract). It would have been obvious to one of ordinary skill in the art at the time of filing the instant claimed invention to modify the trilaminate taught by Ray to have an upper layer with a pore size of 10-20 µm as taught by Tan because the pore size would remove a portion of blood cells from the sample.
Ray in view of Tan does not explicitly teach wherein greater than or equal to 20% of the pores of the second layer have a pore size of less than or equal to 20 microns.
However, Murray teaches a separation membrane having a pore size ranging from about 0.1-20 microns for the purpose of serum/plasma separation (i.e., wherein greater than or equal to 20% of the pores of the second layer have a pore size of less than or equal to 20 microns; Paragraph 0049).
Murray is analogous to the claimed invention because it pertains to devices for selective separation of liquid biological specimens (Abstract). It would have been obvious to one of ordinary skill in the art at the time of filing the instant claimed invention to modify the trilaminate made obvious by Ray in view of Tan with the middle layer having a pore size of 0.1-20 microns as taught by Murray because the middle layer would be suitable for serum/plasma separation.
Ray in view of Tan in view of Murray does not explicitly teach a third layer that has an absorbency of greater than or equal to 80 microliters/cm2 and less than or equal to 600 microliters/cm2.
However, Allen teaches a pad for receiving fluid from a second membrane that has a surface area of 5 to 50 mm2 and a volume capacity of 1 to 30 µL, which converts to an absorbency range of 2-600 µL/cm2, and further teaches that the thickness of the material can be in a range of 0.1 to 2 mm, for the purpose of absorbing and reacting with a component of the plasma (i.e., a third layer that has an absorbency of greater than or equal to 80 microliters/cm2 and less than or equal to 600 microliters/cm2; Col. 4, Lines 3-20). The thickness of the material is not taken into account via the claim limitation and greater thickness would result in greater absorbency per unit area. Therefore, even if the range of absorbency is not fully 2-600 µL/cm2, the range lies somewhere between these values and still overlaps the range of instant claim 1.
Allen is analogous to the claimed invention because it pertains to a construction providing for removing interfering blood cells from a blood sample (Abstract). It would have been obvious to one of ordinary skill in the art at the time of filing the instant claimed invention to modify the trilaminate made obvious by Ray in view of Tan in view of Murray with the pad having the absorbency range of 2-600 µL/cm2 as taught by Allen because the pad would absorb and react with a component of the serum.
Ray in view of Tan in view of Murray in view of Allen does not explicitly teach a third layer that has an absorbency of greater than or equal to 80 microliters/cm2 and less than or equal to 600 microliters/cm2. However, a prima facie case of obviousness exists for claimed ranges that overlap or lie inside ranges disclosed by prior art (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976))(See MPEP 2144.05(I)). It would have been obvious to one having ordinary skill in the art to have selected the absorbency that corresponds to the claimed range while experimenting with the range made obvious by Ray in view of Tan in view of Murray in view of Allen.
Regarding Claim 12, Ray in view of Tan in view of Murray in view of Allen makes obvious the article of claim 1. Murray further teaches that that separation membranes are known to have a decreasing porosity that gradually decreases from a top side of the membrane to a bottom side of the membrane so as to trap solid components with a range of 0.1-20 microns (i.e., wherein the second layer has a second mode pore size; Paragraphs 0049) which contains a lower side of the range that is smaller than the entire range taught by Tan which is 10-20 µm (i.e., the second mode pore size is smaller than the first mode pore size of the first layer; Paragraph 0035).
Regarding Claim 17, Ray in view of Tan in view of Murray in view of Allen makes obvious the article of claim 1. Allen further teaches that the reactant pad includes a screen mesh layer with a pore size from about 100 to 300 microns for the purpose of removing superfluous fluid from the reactant pad once the reactant pad is saturated (i.e., wherein the third layer has a third mode pore size, and the third mode pore size is greater than or equal to 20 microns and less than or equal to 150 microns; Col. 4, Lines 58-66). It would have been obvious to one of ordinary skill in the art at the time of filing the instant claimed invention to modify the trilaminate made obvious by Ray in view of Tan in view of Murray in view of Allen with the screen mesh as part of the absorbent layer as taught by Allen because the screen mesh would wick away excess sample.
Ray in view of Tan in view of Murray in view of Allen does not explicitly teach wherein the third layer has a third mode pore size, and the third mode pore size is greater than or equal to 20 microns and less than or equal to 150 microns. However, a prima facie case of obviousness exists for claimed ranges that overlap or lie inside ranges disclosed by prior art (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976))(See MPEP 2144.05(I)). It would have been obvious to one having ordinary skill in the art to have selected the pore size that corresponds to the claimed range while experimenting with the range made obvious by Ray in view of Tan in view of Murray in view of Allen.
Regarding Claim 19, Ray in view of Tan in view of Murray in view of Allen makes obvious the article of claim 1. Murray further teaches that it is known to apply pressure to membranes to release entrained fluid, due to porosity, and release at least 40% of its saturated volume for the purpose of recovering fluid containing an analyte of interest (i.e., wherein the third layer has a release of greater than or equal to 35%; Paragraph 0088). It would have been obvious to one of ordinary skill in the art at the time of filing the instant claimed invention to modify the trilaminate made obvious by Ray in view of Tan in view of Murray in view of Allen with the porosity that relates to at least a 40% release of saturated volume as taught by Murray because the porosity would cause a larger recovery of fluid containing analyte of interest.
Regarding Claim 22, Ray in view of Tan in view of Murray in view of Allen makes obvious the article of claim 1. Murray further teaches that that separation membranes are known to have a decreasing porosity that gradually decreases from a top side of the membrane to a bottom side of the membrane so as to trap solid components with a range of 0.1-20 microns (i.e., wherein the second layer has a gradient in mode pore size between the first surface and the second surface, such that the first surface, which faces the first layer, has a mode pore size, the second surface, which faces the third layer, has a mode pore size, and the mode pore size of the second surface is smaller than the mode pore size of the first surface; Paragraphs 0049).
Regarding Claim 23, Ray in view of Tan in view of Murray in view of Allen makes obvious the article of claim 22. Murray further teaches that the pore size ratio is between 50:1 and 100:1 (i.e., wherein a ratio of the mode pore size of the first surface to the mode pore size of the second surface is greater than or equal to 5:1 and less than or equal to 1,000:1; Paragraph 0049).
Regarding Claim 25, Ray in view of Tan in view of Murray in view of Allen makes obvious the article of claim 1. Ray further teaches a trilaminate configuration (i.e., wherein the second layer is positioned between the first layer and the third layer; Fig. 4A, #90) for the separation of blood and other biological samples comprising a separation layer (i.e., a first porous layer; Fig. 4A, #91), a quantitation member (i.e., a second porous layer; Fig. 4A, #94), and a collection member (i.e., a third layer; Fig. 4A, #97) where the collection member can be an absorbent material (i.e., wherein the third layer is porous; Col. 14, Lines 21-37) where is it clearly seen that the layers are directly in contact and with no intervening layers (i.e., wherein there are no intervening layers between the first layer and the second layer and/or the second layer and the third layer; Fig. 4A).
Regarding Claim 26, Ray in view of Tan in view of Murray in view of Allen makes obvious the article of claim 1. Tan further teaches that various stages of filters can be laminated on top of each other with adhesive rings for the purpose of sealing the edges of the filters when used in a confined environment with pressure as a driving force of separation (i.e., wherein the first layer is adhered to the second layer and/or the second layer is adhered to the third layer; Paragraph 0065). It would have been obvious to one of ordinary skill in the art at the time of filing the instant claimed invention to modify the trilaminate made obvious by Ray in view of Tan in view of Murray in view of Allen with an adhesive ring between filters as taught by Tan because the adhesive ring would prevent leaking around the edge of the filters adhered this way.
Regarding Claim 30, Ray in view of Tan in view of Murray in view of Allen makes obvious the article of claim 1. Ray further teaches that the separation member and collection member can have thickness different from each other to produce particular results (Col. 3, Lines 21-34) and that there can be a spacer with a thickness of 0.5 mm, or 500 microns, which has a perforation that accommodates the separation member (i.e., wherein the first layer has a thickness of greater than or equal to 150 microns and less than or equal to 500 microns; Col 5, Line 56 to Col. 6, Line 9).
Regarding Claim 31, Ray in view of Tan in view of Murray in view of Allen makes obvious the article of claim 1. Murray further teaches that the collection member can have a diameter/width of about 1 to 50 mm (Paragraph 0043) and that the separation membrane has a diameter/width of about 1 to 50 mm (i.e., wherein a maximum horizontal dimension of the first layer, the second layer, and/or the third layer is greater than or equal to 20 millimeters and less than or equal to 500 millimeters; Paragraph 0050).
Ray in view of Tan in view of Murray in view of Allen does not explicitly teach wherein a maximum horizontal dimension of the first layer, the second layer, and/or the third layer is greater than or equal to 20 millimeters and less than or equal to 500 millimeters. However, a prima facie case of obviousness exists for claimed ranges that overlap or lie inside ranges disclosed by prior art (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976))(See MPEP 2144.05(I)). It would have been obvious to one having ordinary skill in the art to have selected the maximum horizontal dimension that corresponds to the claimed range while experimenting with the range made obvious by Ray in view of Tan in view of Murray in view of Allen.
Regarding Claim 32, Ray in view of Tan in view of Murray in view of Allen makes obvious the article of claim 1. Tan further teaches a multi-stage filter system with filter stage 1 having a pore size of 40 µm and filter stage 2 having a pore size of 10-20 µm before the next stage which is an asymmetric filter stage for the purpose of inducing blood cell aggregation and removing a portion of the blood cells not removed by the aggregation (i.e., wherein the first layer comprises greater than or equal to 2 sub-layers and less than or equal to 4 sub-layers; Paragraph 0035). It would have been obvious to one of ordinary skill in the art at the time of filing the instant claimed invention to modify the trilaminate made obvious by Ray in view of Tan in view of Murray in view of Allen with the multi-stage filter as taught by Tan because the multi-stage filter would aggregate and remove blood cells.
Regarding Claim 33, Ray in view of Tan in view of Murray in view of Allen makes obvious the article of claim 32. Tan further teaches a multi-stage filter system with filter stage 1 having a pore size of 40 µm and filter stage 2 having a pore size of 10-20 µm (i.e., wherein each of the sub-layers has a different mode pore size and the sub-layers are arranged such that a gradient in mode pore size is formed; Paragraph 0035).
Regarding Claim 35, Ray in view of Tan in view of Murray in view of Allen makes obvious the article of claim 1. Ray further teaches a separation layer (i.e., a first porous layer; Fig. 4A, #91) that is composed of glass fibers or nylon (i.e., wherein the first layer comprises a fibrous membrane, nylon, and/or mesh; Col. 12, Lines 12-15).
Regarding Claim 37, Ray in view of Tan in view of Murray in view of Allen makes obvious the article of claim 1. Ray further teaches a quantitation member (i.e., a second porous layer; Fig. 4A, #94) that may be composed of multiple layers including nylon and cellulose (i.e., wherein the second layer comprises a polymer; Col. 5, Lines 17-30).
Regarding Claim 40, Ray in view of Tan in view of Murray in view of Allen makes obvious the article of claim 1. Ray further teaches a collection member (i.e., a third layer; Fig. 4A, #97) that is composed of polyester and/or cellulose (i.e., wherein the third layer comprises polyester; Col. 18, Lines 47-67).
Regarding Claim 42, Ray in view of Tan in view of Murray in view of Allen makes obvious the article of claim 1. Ray further teaches that any device can include a cover sheet or casing for protecting the absorbent collection or separation members (i.e., wherein the article further comprises a support structure; Col. 20, Lines 32-43)
Regarding Claim 46, Ray in view of Tan in view of Murray in view of Allen makes obvious the article of claim 1. Ray further teaches that the separation member and collection member can have thickness different from each other to produce particular results (Col. 3, Lines 21-34). Murray further teaches that a collection membrane can have a thickness of 0.19 to 0.27 mm, or 190 to 270 µm (i.e., wherein the third layer has a thickness of greater than or equal to 200 microns and less than or equal to 800 microns; Paragraph 0076). It would have been obvious to one of ordinary skill in the art at the time of filing the instant claimed invention to modify the trilaminate made obvious by Ray in view of Tan in view of Murray in view of Allen with the thickness of the collection member as taught by Murray because the varying thickness would produce different results for different samples.
Ray in view of Tan in view of Murray in view of Allen does not explicitly teach wherein the third layer has a thickness of greater than or equal to 200 microns and less than or equal to 800 microns. However, a prima facie case of obviousness exists for claimed ranges that overlap or lie inside ranges disclosed by prior art (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976))(See MPEP 2144.05(I)). It would have been obvious to one having ordinary skill in the art to have selected the thickness that corresponds to the claimed range while experimenting with the range made obvious by Ray in view of Tan in view of Murray in view of Allen.
Regarding Claim 48, Ray in view of Tan in view of Murray in view of Allen makes obvious the article of claim 1. Ray further teaches that the separation member can be absorbent or non-absorbent for delivering the sample to the serum/plasma collection member via capillary action (Col. 2, Line 64 to Col. 3, Line 8), that the device as a whole will have a minimum threshold volume between 2 µL to 25 µL to reduce sample size, that the retention volume should be a specific volume that does not change if the loaded sample is above the threshold volume for making measurements more accurate, and gives an example of the collection member retention volume of 8 µL (Col. 19, Lines 24-60). The teachings from Ray imply that the separation member retention volume can be tuned, but is likely less than that of the collection member. As such, given the example of 8 µL, which converts to an absorbency of 47 µL/cm2, the absorbency of the separation member is less than 47 µL/cm2 (i.e., wherein the first layer has an absorbency of greater than or equal to 10 microliters/cm2 and less than or equal to 100 microliters/cm2). The more general range taught by Ray is that the total absorbency must be less than the threshold volume range of 2 µL to 25 µL, which converts to an absorbency range of less than 11 to 147 µL/cm2.
Ray in view of Tan in view of Murray in view of Allen does not explicitly teach wherein the first layer has an absorbency of greater than or equal to 10 microliters/cm2 and less than or equal to 100 microliters/cm2. However, a prima facie case of obviousness exists for claimed ranges that overlap or lie inside ranges disclosed by prior art (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976))(See MPEP 2144.05(I)). It would have been obvious to one having ordinary skill in the art to have selected the absorbency that corresponds to the claimed range while experimenting with the range made obvious by Ray in view of Tan in view of Murray in view of Allen.
Furthermore, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation absent unexpected results or evidence indicating such optimum or workable ranges are critical (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); MPEP§2144.05).
Regarding Claim 50, Ray in view of Tan in view of Murray in view of Allen makes obvious the article of claim 1. Ray further teaches that the quantitation member can be made to deliver a predetermined volume of sample to another component (Col. 2, Lines 54-63), that the device as a whole will have a minimum threshold volume between 2 µL to 25 µL to reduce sample size, that the retention volume should be a specific volume that does not change if the loaded sample is above the threshold volume for making measurements more accurate, and gives an example of the collection member retention volume of 8 µL (Col. 19, Lines 24-60). The teachings from Ray imply that the quantitation member retention volume can be tuned, but is likely less than that of the collection member. As such, given the example of 8 µL, which converts to an absorbency of 47 µL/cm2, the absorbency of the quantitation member is less than 47 µL/cm2 (i.e., wherein the second layer has an absorbency of greater than or equal to 10 microliters/cm2 and less than or equal to 50 microliters/cm2). The more general range taught by Ray is that the total absorbency must be less than the threshold volume range of 2 µL to 25 µL, which converts to an absorbency range of less than 11 to 147 µL/cm2.
Ray in view of Tan in view of Murray in view of Allen does not explicitly teach wherein the second layer has an absorbency of greater than or equal to 10 microliters/cm2 and less than or equal to 50 microliters/cm2. However, a prima facie case of obviousness exists for claimed ranges that overlap or lie inside ranges disclosed by prior art (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976))(See MPEP 2144.05(I)). It would have been obvious to one having ordinary skill in the art to have selected the absorbency that corresponds to the claimed range while experimenting with the range made obvious by Ray in view of Tan in view of Murray in view of Allen.
Furthermore, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation absent unexpected results or evidence indicating such optimum or workable ranges are critical (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); MPEP§2144.05).
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/A.A.G./ Examiner, Art Unit 1777
/Ryan B Huang/ Primary Examiner, Art Unit 1777
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