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 .
Response to Arguments
Applicant's arguments filed 12/22/2025 have been fully considered but they are not persuasive. Regarding the argument that the membrane filter of Gourlay ‘446 does not teach the claim limitation of “a depth filtration function”, this argument is unpersuasive. The applicant states that the “flat sheet membrane” of Gourlay ‘446 does not have “a depth filtration function” (Page 1-2 of Request for Reconsideration, mailed on 12/22/2025). However, it is an inherent property of a membrane filter to have a thickness/depth that contains pores for capturing particulates. Thus, when the particulates travel through the membrane filter of Gourlay ‘446, particulates smaller than the given pore size will travel through the membrane filter, particulates slightly smaller, same, or slightly larger than the given pore size will get lodged within the pore within the depth of the membrane filter, or depth filtration function, and particulates larger than the pore will be trapped on the surface of the membrane filter, or screen filtration function. The depth filtration function is an inherent property of the membrane filter to perform the function of separating larger particulates from smaller particulates through the pores of the filter. It is not understood why the membrane filter of Gourlay ‘446 that is fully capable of performing the screen filtration function or the depth filtration function would not disclose the claim limitation of the claimed invention.
Furthermore, the claim limitation “characterized in that the membrane filter of the inner bag is a membrane filter having both a screen filtration function and a depth filtration function” is a recitation of an intended use of the membrane filter. Although the prior art of Gourlay ‘446 does not expressly state “characterized in that the membrane filter of the inner bag is a membrane filter having both a screen filtration function and a depth filtration function”, since the device of the prior art is substantially identical to the membrane filter of the claimed device, it must also necessarily produce the same outcome. Therefore, the claim limitation is anticipated by the prior art of Gourlay ‘446. Wherein the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
In pages 2-4 of the Request for Reconsideration, mailed on 12/22/2025, the applicant further provides examples of a surface filter (Figure 3) and a depth filter (Figure 4). However, the material of the filter provided in the applicant’s example of Figure 3, a polycarbonate sheet membrane, while the material of the filter in the prior art of Gourlay ‘446 is polyethersulfone, similar to the material of the filter of the claimed invention. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the differences in the structure of the surface filter of Figure 3 and the depth filter of Figure 4) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Since neither “a surface filter” and “a depth filter” are claimed in the claim limitation of claim 1 and only the function is recited, the prior art of Gourlay ‘446 discloses the device of claim 1.
In page 4 of the Request for Reconsideration, mailed on 12/22/2025, the applicant argues that Gourlay ‘446 does not disclose “an inner bag that is fastened to, and suspended within, the outer bag”. However, Gourlay ‘446 discusses that the member 10’ with the membrane 14’ is attached to the inner wall of the container 5’ (Column 9, lines 58-63 and Column 10, lines 51-52), where the attachment points of the member 10’ to the inner wall of the container 5’ would be the top and the bottom of the container (see Figures 1a-1c) and suspending the member 10’ within the container 5’, allowing for movement of the sides of the inner bag for filtration. The term “suspend” is interpreted to mean “to hang”, as defined by Cambridge Dictionary (see PTO-892 attached).
On page 4-8 of the Request for Reconsideration, mailed on 12/22/2025, the applicant argues that Cotton ‘319, Cotton ‘988, Gourlay ‘343, and Bieberich does not teach a screen filtration function and a depth filtration function. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, Gourlay ‘446 already teaches the claimed limitations as evident above.
On page 4-8 of the Request for Reconsideration, mailed on 12/22/2025, the applicant argues that the teaching of the burst pressure of Ashitaka is unsuitable for the membrane filter of Gourlay ‘446. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the argument is unpersuasive since the porous membrane of Gourlay ‘446 is analogous to the hollow membrane of Ashitaka, with both membranes having the function of filtering particulates from the fluid that travels through the filter. Thus, the teaching of the burst pressure of Ashitaka is applicable to the membrane filter of Gourlay ‘446, to prevent the deformation of the filter.
For these reasons, Applicant’s arguments are unpersuasive and claims 1-20 stand rejected.
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.
Claim(s) 1-2, 7, 9-10, 13, and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gourlay (Patent No. US 9,636,446 B2), hereby referred to as “Gourlay ‘446”.
Regarding claim 1, Gourlay ‘446 discloses a haemoconcentration device (apparatus 1’; Figure 2a-c; Claim 1; Column 9, lines 53-57) comprising:
an outer bag formed from an impermeable material (outer wall of container 5’ is made of a fluid impermeable flexible bag/pouch; Figure 2a-c; Column 9, lines 53-57);
an inner bag formed from a hydrophilic membrane filter (filtration member 10’ having a membrane 14’ made of hydrophilic polyethersulfone; Figure 2a-2c; Column 9, lines 9-19 and 58-63); and
an absorbent material (superabsorbent material 20’; Column 9, lines 58-63; Figure 2a-2c);
wherein the absorbent material is enclosed within the inner bag (Column 9, lines 58-63; Figure 2a-2c) and the inner bag is fastened to, and suspended within, the outer bag (member 10’ with membrane 14’ is suspended and attached within container 5’; Column 9, lines 58-63 and Column 10, lines 51-52);
characterized in that the membrane filter of the inner bag is a membrane filter having both a screen filtration function and a depth filtration function (filtration member 10’ has a membrane 14’ – inherent that a membrane filter would be able to capture particulates on the surface of and within the filter; Column 9, lines 9-22).
Furthermore, the claim limitation “characterized in that the membrane filter of the inner bag is a membrane filter having both a screen filtration function and a depth filtration function” is a recitation of an intended use of the membrane filter. Although the prior art of Gourlay ‘446 does not expressly disclose “characterized in that the membrane filter of the inner bag is a membrane filter having both a screen filtration function and a depth filtration function”, since the device of the prior art is substantially identical to the claimed device, it must also necessarily produce the same outcome. Therefore, the claim limitation is anticipated by the prior art of Gourlay ‘446. Wherein the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Regarding claim 2, Gourlay ‘446 discloses the device of claim 1. Gourlay ‘446 further discloses wherein the membrane filter has a nominal pore size of about 3 µm (Claim 1 – “wherein the permeable membrane has an effective pore size of 0.2-8 μm”; Column 4, lines 29-36).
Regarding claim 7, Gourlay ‘446 discloses the device of claim 1. Gourlay ‘446 further discloses wherein the membrane filter is a polyethersulfone (PES) membrane filter (filtration member 10’ having a membrane 14’ made of hydrophilic polyethersulfone; Figure 2a-2c; Column 9, lines 9-19 and 58-63).
Regarding claim 9, Gourlay ‘446 discloses the device of claim 1. Gourlay ‘446 further discloses wherein the outer bag comprises an inlet port for the introduction of haemodiluted blood (first opening 25’ to introduce fluid 15’ wherein the fluid is blood; Figure 2a-2c; Column 1, lines 9-12, Column 10, lines 6-10, and Column 12, lines 4-19).
Regarding claim 10, Gourlay ‘446 discloses the device of claim 1. Gourlay ‘446 further discloses wherein the outer bag comprises an outlet port for the drainage of processed blood (processed fluid leaves second opening 40’; Figure 2a-2c; Column 11, lines 1-8).
Regarding claim 13, Gourlay ‘446 discloses the device of claim 1. Gourlay ‘446 further discloses wherein the outer bag is formed from polyvinylchorine (PVC) (Column 8, lines 60-63).
Regarding claim 15, Gourlay ‘446 discloses the device of claim 1. Gourlay ‘446 further discloses wherein the absorbent material is a superabsorbent material (Column 4, lines 37-40).
Regarding claim 16, Gourlay ‘446 discloses the device of claim 1. Gourlay ‘446 further discloses wherein the superabsorbent material is a polyacrylate superabsorbent material (Column 4, lines 37-40).
Regarding claim 17, Gourlay ‘446 discloses the device of claim 1. Gourlay ‘446 further discloses wherein the superabsorbent material is in solid sheet form (superabsorbent material is pad structured, a pad structure resembles a flat sheet; Column 3, lines 15-20 and Column 10, lines 40-45).
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(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Gourlay (Patent No. US 9,636,446 B2).
Regarding claim 19, Gourlay ‘446 discloses the device of claim 1. Gourlay ‘446 does not teach wherein the amount of superabsorbent material included in the device is from about 3 g to about 15 g.
However, it would have been obvious of one of ordinary skill in the art to have the superabsorbent material of Gourlay ‘446 to be sized to be about 15 grams of polyacrylate material since the size of an article is not a matter of invention. See In re Rose, 105 USPQ 237 (CCPA 1955) (see MPEP § 2144.04).
Claim(s) 3, 5, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Gourlay (Patent No. US 9,636,446 B2) in view of Cotton et al. (Publication No. US 2012/0175319 A1), hereby referred to as “Cotton ‘319”.
Regarding claim 3, Gourlay ‘446 discloses the device of claim 1. Gourlay ‘446 does not teach wherein the membrane filter has a thickness of about 130 µm to about 180 µm.
However, Cotton ‘319 teaches wherein the membrane filter has a thickness of about 130 µm to about 180 µm (thickness of inner bag with membrane filter between 0.1 mm and 2 mm, or 100 to 2000 micrometer; Paragraph 0013-0014).
Gourlay ‘446 and Cotton ‘319 are both considered to be analogous to the claimed invention because they are in the same field of blood filtering devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gourlay ‘446 to incorporate the teachings of Cotton ‘319 and have the membrane filter of Gourlay ‘446 to have a thickness of about 130 µm to about 180 µm, as taught by Cotton ‘319. This allows for the membrane filter to allow liquid medium to pass through while preventing the passage of particulate by capturing it in its membrane (Cotton ‘319; Paragraph 0015).
In addition, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the membrane filter has a thickness of about 130 µm to about 180 µm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the membrane would not operate differently with the claimed thickness since it has the same function of filtering blood through the device. Further, applicant places no criticality on the range claimed, indicating simply that the thickness is “about” the ranges (Claim 3; specification; Paragraph 0053-0054).
Regarding claim 5, Gourlay ‘446 discloses the device of claim 1. Gourlay ‘446 does not teach wherein the membrane filter is heat weldable.
However, Cotton ‘319 teaches wherein the membrane filter is heat weldable (Paragraph 0009, 0057, and 0062).
Gourlay ‘446 and Cotton ‘319 are both considered to be analogous to the claimed invention because they are in the same field of blood filtering devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gourlay ‘446 to incorporate the teachings of Cotton ‘319 and have the membrane filter of Gourlay ‘446 to be heat weldable, as taught by Cotton ‘319. This allows for the device to create a welded portion between the inner and outer bag that is sturdy for hanging the device using a support (Cotton ‘319; Paragraph 0062) and avoid the introduction of adhesive and contaminants into the bag (Cotton ‘319; Paragraph 0009).
Regarding claim 14, Gourlay ‘446 discloses the device of claim 1. Gourlay ‘446 does not teach wherein the outer bag has a thickness of from about 0.2 mm to about 3.0 mm.
However, Cotton ‘319 teaches wherein the outer bag has a thickness of from about 0.2 mm to about 3.0 mm (thickness of outer bag is typically between 0.2 to 3 mm; Paragraph 0011).
Gourlay ‘446 and Cotton ‘319 are both considered to be analogous to the claimed invention because they are in the same field of blood filtering devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gourlay ‘446 to incorporate the teachings of Cotton ‘319 and have the outer bag of Gourlay ‘446 has a thickness of from about 0.2 mm to about 3.0 mm, as taught by Cotton ‘319. This allows for the device to be a flexible bag that is impermeable to contain the fluid in the device (Cotton ‘319; Paragraph 0008 and 0010).
In addition, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the outer bag has a thickness of from about 0.2 mm to about 3.0 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the outer bag layer would not operate differently with the claimed thickness since it has the same function of holding blood/fluid that is in the device. Further, applicant places no criticality on the range claimed, indicating simply that the thickness is “about” the ranges (Claim 14; specification; Paragraph 0046).
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Gourlay (Patent No. US 9,636,446 B2) in view of Ashitaka et al. (Publication No. US 2015/0232506 A1).
Regarding claim 4, Gourlay ‘446 discloses the device of claim 1. Gourlay ‘446 does not teach wherein the membrane filter has a burst pressure of at least 0.2 bar.
However, Ashitaka teaches wherein the membrane filter has a burst pressure of at least 0.2 bar (burst pressure when liquid is traveling through the filter is 7.5 bar or more; Paragraph 0042).
Gourlay ‘446 and Ashitaka are both considered to be analogous to the claimed invention because they are in the same field of blood filtering membranes. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gourlay ‘446 to incorporate the teachings of Ashitaka and have the membrane filter of Gourlay ‘446 to have the burst pressure, as taught by Ashitaka. This allows for the filter to have a high resistance against the deformation of the filter (Ashitaka; Paragraph 0042).
Claim(s) 6 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Gourlay (Patent No. US 9,636,446 B2) in view of Cotton et al. (Publication No. US 2021/0015988 A1), hereby referred to as “Cotton ‘988”).
Regarding claim 6, Gourlay ‘446 discloses the device of claim 1. Gourlay does not teach wherein the membrane filter has an air flow rate of at least 20 L/m2.s.200Pa.
However, Cotton ‘988 teaches wherein the membrane filter has an air flow rate of at least 20 L/m2.s.200Pa (Paragraph 0012; Claim 4).
Gourlay ‘446 and Cotton ‘988 are both considered to be analogous to the claimed invention because they are in the same field of blood filtering devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gourlay ‘446 to incorporate the teachings of Cotton ‘988 and have the membrane filter of Gourlay ‘446 to have the air flow rate of Cotton ‘988. This allows for the device to have a high porous membrane for an effective separation of plasma from blood (Cotton ‘988; Paragraph 0012).
Regarding claim 12, Gourlay ‘446 discloses the device of claim 1. Gourlay does not teach wherein the outer bag is adapted to accommodate a volume of blood of up to about 1 litre.
However, Cotton ‘988 teaches wherein the outer bag is adapted to accommodate a volume of blood of up to about 1 litre (collector may have a volume of 1 to 5 liters; Paragraph 0040).
Gourlay ‘446 and Cotton ‘988 are both considered to be analogous to the claimed invention because they are in the same field of blood filtering devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gourlay ‘446 to incorporate the teachings of Cotton ‘988 and have the outer bag of Gourlay ‘446 to have a volume of 1 liter, as taught by Cotton ‘988. This allows for the device to provide sufficient space of blood and reduce the spillage of plasma (Cotton ‘988; Paragraph 0040).
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Gourlay (Patent No. US 9,636,446 B2) in view of Cotton et al. (Publication No. US 2021/0015988 A1), Cotton et al. (Publication No. US 2012/0175319 A1), and Ashitaka et al. (Publication No. US 2015/0232506 A1).
Regarding claim 8, Gourlay ‘446 discloses the device of claim 1. Gourlay ‘446 further teaches wherein the membrane filter is a hydrophilic polyethersulfone membrane (filtration member 10’ having a membrane 14’ made of hydrophilic polyethersulfone; Figure 2a-2c; Column 9, lines 9-19 and 58-63) with: a nominal pore size of 3 µm (Claim 1 – “wherein the permeable membrane has an effective pore size of 0.2-8 μm”; Column 4, lines 29-36). Gourlay ‘446 does not teach an air flow rate of at least 20 L/m2.s.200Pa.
However, Cotton ‘998 teaches an air flow rate of at least 20 L/m2.s.200Pa (Paragraph 0012; Claim 4).
Gourlay ‘446 and Cotton ‘988 are both considered to be analogous to the claimed invention because they are in the same field of blood filtering devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gourlay ‘446 to incorporate the teachings of Cotton ‘988 and have the membrane filter of Gourlay ‘446 to have the air flow rate of Cotton ‘988. This allows for the device to have a high porous membrane for an effective separation of plasma from blood (Cotton ‘988; Paragraph 0012).
The combination of Gourlay ‘446 in view of Cotton ‘988 does not teach a thickness of about 130 µm to about 180 µm.
However, Cotton ‘319 teaches a thickness of about 130 µm to about 180 µm (thickness of inner bag with membrane filter between 0.1 mm and 2 mm, or 100 to 2000 micrometer; Paragraph 0013-0014).
Gourlay ‘446 in view of Cotton ‘998 and Cotton ‘319 are both considered to be analogous to the claimed invention because they are in the same field of blood filtering devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gourlay ‘446 in view of Cotton ‘998 to incorporate the teachings of Cotton ‘319 and have the membrane filter of Gourlay ‘446 in view of Cotton ‘998 to have a thickness of about 130 µm to about 180 µm, as taught by Cotton ‘319. This allows for the membrane filter to allow liquid medium to pass through while preventing the passage of particulate by capturing it in its membrane (Cotton ‘319; Paragraph 0015).
In addition, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the membrane filter has a thickness of about 130 µm to about 180 µm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the membrane would not operate differently with the claimed thickness since it has the same function of filtering blood through the device. Further, applicant places no criticality on the range claimed, indicating simply that the thickness is “about” the ranges (Claim 3; specification; Paragraph 0053-0054).
The combination of Gourlay ‘446 in view of Cotton ‘988 and Cotton ‘319 does not teach a burst pressure of at least 0.2 bar.
However, Ashitaka teaches a burst pressure of at least 0.2 bar (burst pressure when liquid is traveling through the filter is 7.5 bar or more; Paragraph 0042).
Gourlay ‘446 in view of Cotton ‘988 and Cotton ‘319 and Ashitaka are both considered to be analogous to the claimed invention because they are in the same field of blood filtering membranes. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gourlay ‘446 in view of Cotton ‘988 and Cotton ‘319 to incorporate the teachings of Ashitaka and have the membrane filter of Gourlay ‘446 in view of Cotton ‘988 and Cotton ‘319 to have the burst pressure, as taught by Ashitaka. This allows for the filter to have a high resistance against the deformation of the filter (Ashitaka; Paragraph 0042).
Claim(s) 11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Gourlay (Patent No. US 9,636,446 B2) in view of Gourlay (Publication No. US 2011/0272343 A1), hereby referred to as “Gourlay ‘343”.
Regarding claim 11, Gourlay ‘446 discloses the device of claim 1. Gourlay ‘446 does not teach wherein the outer bag comprises an inlet port for the introduction of primer fluid.
However, Gourlay ‘343 teaches wherein the outer bag comprises an inlet port for the introduction of primer fluid (Paragraph 0069).
Gourlay ‘446 and Gourlay ‘343 are both considered to be analogous to the claimed invention because they are in the same field of blood filtering devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gourlay ‘446 to incorporate the teachings of Gourlay ‘343 and have the outer bag of Gourlay ‘446 have the inlet port to receive priming fluid, as taught by Gourlay ‘343. This allows for the device to be flushed before inputting blood into the device to exclude gas from the device (Gourlay ‘343; Paragraph 0069; Claim 53).
Regarding claim 20, Gourlay ‘446 teaches a method for haemoconcentration (Abstract), which method involves the steps of:
providing a haemoconcentration device (apparatus 1’; Figure 2a-c; Claim 1; Column 9, lines 53-57) comprising an outer bag formed from an impermeable material (outer wall of container 5’ is made of a fluid impermeable flexible bag/pouch; Figure 2a-c; Column 9, lines 53-57); an inner bag formed from a hydrophilic membrane filter material (filtration member 10’ having a membrane 14’ made of hydrophilic polyethersulfone; Figure 2a-2c; Column 9, lines 9-19 and 58-63); and an absorbent material (superabsorbent material 20’; Column 9, lines 58-63; Figure 2a-2c); the absorbent material being enclosed within the inner bag (Column 9, lines 58-63; Figure 2a-2c) and the inner bag being fastened to, and suspended within, the outer bag (member 10’ with membrane 14’ is suspended and attached within container 5’; Column 9, lines 58-63 and Column 10, lines 51-52); and the membrane filter of the inner bag being a membrane filter having both a screen filtration function and a depth filtration function (filtration member 10’ has a membrane 14’ – inherent that a membrane filter would be able to capture particulates on the surface of and within the filter; Column 9, lines 9-22);
introducing haemodiluted blood into the outer bag (Column 6, lines 43-53; Claim 10);
agitating the blood for example by placing the haemoconcentration device on an shaker unit (Claim 11; Column 6, lines 54-59 and Column 12, lines 6-37); and
continuing said agitation until a desired blood packed cell volume is reached (Column 12, lines 6-37). Gourlay ‘446 does not teach introducing a primer solution into the device, to wet the membrane filter and prime the absorbent material.
However, Gourlay ‘343 teaches introducing a primer solution into the device, to wet the membrane filter and prime the absorbent material (Paragraph 0069).
Gourlay ‘446 and Gourlay ‘343 are both considered to be analogous to the claimed invention because they are in the same field of blood filtering devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gourlay ‘446 to incorporate the teachings of Gourlay ‘343 and have the outer bag of Gourlay ‘446 have the inlet port to receive priming fluid, as taught by Gourlay ‘343. This allows for the device to be flushed before inputting blood into the device to exclude gas from the device (Gourlay ‘343; Paragraph 0069; Claim 53).
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Gourlay (Patent No. US 9,636,446 B2) in view of Bieberich (Publication No. US 2002/0058975 A1).
Regarding claim 18, Gourlay ‘446 discloses the device of claim 1. Gourlay ‘446 further teaches wherein the super absorbent material such as polyacrylates may absorb up to 200, 400, or 500 times or more their weight of water. Gourlay ‘446 does not expressly teach wherein the superabsorbent material is capable of absorbing at least about 600 ml of fluid.
However, Bieberich teaches wherein the 30 grams of polyacrylate superabsorbent material is capable of absorbing about 1000 grams of fluid (Paragraph 0041).
Gourlay ‘446 and Bieberich are both considered to be analogous to the claimed invention because they are in the same field of superabsorbent polymer devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gourlay ‘446 to incorporate the teachings of Bieberich and have the superabsorbent polymer of Gourlay ‘446 have the absorbent properties as taught by Bieberich. This allows for the device to effectively absorb water and reduce heat (Bieberich; Paragraph 0041).
It would have been obvious of one of ordinary skill in the art to have the superabsorbent material of Gourlay ‘446 in view of Bieberich to be sized to be about 20 grams of polyacrylate material since the size of an article is not a matter of invention. See In re Rose, 105 USPQ 237 (CCPA 1955) (see MPEP § 2144.04). The combination of Gourlay ‘446 in view of Bieberich further teaches wherein the superabsorbent material is capable of absorbing at least about 600 ml of fluid (Bieberich; about 20 grams of polyacrylate material would absorb about 650 mL of fluid; see combination above).
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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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781