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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/06/2026 has been entered.
Response to Amendment
Applicant’s amendments filed on 07/06/2026 have been fully considered. Claims 1-20 are pending in this application. Claim 1 is amended.
Response to Arguments
Applicant's arguments, regarding the 35 U.S.C. 102 rejection of independent claim 1 in view of Gourlay ‘446, filed 07/06/2026 have been fully considered but they are not persuasive.
Regarding the argument of Gourlay ‘446 not teaching “a membrane filter having both a screen filtration function and a depth filtration function”, the argument is unpersuasive. As previously discussed in the Final Rejection, mailed 03/03/2026, the Examiner explained that “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. This means that if the device with the membrane filter has similar structure and material properties of the claimed invention, the membrane filter is fully capable of performing the function required. The membrane filter of Gourlay ‘446 has a surface area and a thickness which will enable fluid, such as blood to travel through, and will result in capturing particulates at the filter’s surface, in between the opening of the pores, and through the thickness of the filter, within the pores. Thus, the prior art of Gourlay ‘446 would be performing “a screen filtration function” and “a depth filtration function”, similar to the claimed invention.
The declaration under 37 CFR 1.132 filed 07/06/2026 is insufficient to overcome the rejection of independent claim 1 and its dependents based upon the 35 U.S.C. 102(a)(1) rejection as being anticipated by Gourlay (Patent No. US 9,636,446 B2), hereby referred to as Gourlay ‘446, as set forth in the last Office action because:
The Examiner appreciates the submission of the Inventor’s Curriculum Vitae and the Inventor’s presentation of arguments between the prior art used in the rejection of record, which is also the patent held by the Inventor, Gourlay ‘446, however, the presented arguments and exhibit does not provide sufficient evidence to overcome the disclosure of the membrane filter of Gourlay ‘446 being fully capable of performing the function of both “a screen filtration function” and “a depth filtration function”, with the reasons addressed above. The Examiner interpreted the performance of the “screen filtration function” as the ability of the filter capturing pores larger than its pore size on the surface (specification of instant application; Paragraph 0012). The prior art of Gourlay ‘446 has a microporous structure that would inherently capture particulates with a diameter larger than the diameter of its pore size. The Examiner interpreted the performance of the “depth filtration function” as the ability of filter in capturing particulates through its depth to trap and retain particulates (specification of instant application; Paragraph 0013). The prior art of Gourlay ‘446 has a microporous structure that would inherently capture particulates with a diameter equal to or slightly larger than the diameter of the pore to be lodged into the pore through the thickness of the filter, without allowing the particulate to pass through the other end of the filter.
However, the Examiner agrees that the proposed amendment present in the argument and addressed in the declaration of “the membrane filter… comprises a matrix of randomly oriented, bonded fibres”, further narrows the scope of the claimed invention of claim 1 and renders the arguments moot.
Regarding the argument of the embodiment of the “Celgard 2500” flat sheet membrane of Gourlay ‘446, the argument is unpersuasive. In the Final Rejection, mailed on 03/03/2026, the Examiner relied on the embodiment of the membrane filter being made of a hydrophilic polyethersulfone, thus the argument with regards to the “Celgard 2500” embodiment is unapplicable to the previously presented rejection. Although paragraph 0139 of Gourlay ‘446 does not specify the membrane made of “a MicroPES.RTM. polyethersulfone hydrophilic flat membrane (Type "4F toa", "5F M", or "6F") from Membrana GmbH, Oehder Stra.beta.e 28, D-42289 Wuppertal, Germany” “comprises a matrix of randomly oriented, bonded fibres”, the new grounds of rejection below will address the amended claim limitation.
The Examiner further suggests that the “depth filtration function” and “screen filtration function” claim language of independent claim 1 should be fortified using structural language to further narrow the scope of the claim to specify the differences between the membrane filter of the claimed invention from the prior art of record.
Applicant’s arguments with respect to amended claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Though overall the same prior art references are used herein, at least applicant’s amended independent claim 1 required a change in the grounds of rejection as detailed below in the prior art rejection.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, line 7: “a membrane filter” should read “the membrane filter”. Appropriate correction is required.
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.
Claim(s) 1-2, 6-7, 9-10, 13, 15-17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Gourlay (Patent No. US 9,636,446 B2), hereby referred to as “Gourlay ‘446”, in view of McIntosh et al. (Publication No. US 2021/0402354 A1).
Regarding claim 1, Gourlay ‘446 teaches 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 flat membrane, MicroPES from Membrana GmbH; 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).
Gourlay ‘446 does not explicitly teach the membrane filter comprises a matrix of randomly oriented, bonded fibres.
However, McIntosh teaches the membrane filter comprises a matrix of randomly oriented, bonded fibres (MicroPES membrane is a membrane that comprises a matrix of randomly oriented bonded fibres; Figure 1; Paragraph 0006).
Gourlay ‘446 and McIntosh are both considered to be analogous to the claimed invention because they are in the same field of fluid 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 McIntosh and have the polyether sulfone membrane of Gourlay ‘446 to have a matrix of randomly oriented bonded fibres, as taught by McIntosh. This allows for the membrane filter to remove bacteria from solutions through the throughput of the membrane (McIntosh; Paragraph 0002).
Regarding claim 2, Gourlay ‘446 in view of McIntosh teaches the device of claim 1. The combination of Gourlay ‘446 in view of McIntosh does not expressly teach wherein the membrane filter has a nominal pore size of about 3 µm.
However, Gourlay ‘446 teaches wherein the effective membrane pore size is in the range of approximately 0.1 to 10 µm (Claim 53).
Since the prior art of Gourlay ‘446 recognizes the equivalency of having a pore size of 3 µm in the field of blood filtering membranes, it would have been obvious to a person having ordinary skill in the art to substitute the membrane filter pore size of Gourlay ‘446 in view of McIntosh to be 3 µm, as it is merely the selection of functionally equivalent pore sizes recognized in the art and one of ordinary skill in the art would have a reasonable expectation of doing so. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 - 97 (2007) (see MPEP § 2143, B.).
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 with a nominal pore size of about 3 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 pore size 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 2; specification; Paragraph 0041, 0053, and 0060).
Regarding claim 6, Gourlay ‘446 in view of McIntosh teaches the device of claim 1. The combination of Gourlay ‘446 in view of McIntosh does not expressly teach wherein the membrane filter has an air flow rate of at least 20 L/m2.s.200Pa.
However, 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 with an air flow rate of at least 20 L/m2.s.200Pa 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 air flow rate 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 flow rate is the claimed range (Claim 6; specification; Paragraph 0056).
Regarding claim 7, Gourlay ‘446 in view of McIntosh teaches the device of claim 1. Gourlay ‘446 further teaches 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 in view of McIntosh teaches the device of claim 1. Gourlay ‘446 further teaches 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 in view of McIntosh teaches the device of claim 1. Gourlay ‘446 further teaches 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 in view of McIntosh teaches the device of claim 1. Gourlay ‘446 further teaches wherein the outer bag is formed from polyvinylchorine (PVC) (Column 8, lines 60-63).
Regarding claim 15, Gourlay ‘446 in view of McIntosh teaches the device of claim 1. Gourlay ‘446 further teaches wherein the absorbent material is a superabsorbent material (Column 4, lines 37-40).
Regarding claim 16, Gourlay ‘446 in view of McIntosh teaches the device of claim 1. Gourlay ‘446 further teaches wherein the superabsorbent material is a polyacrylate superabsorbent material (Column 4, lines 37-40).
Regarding claim 17, Gourlay ‘446 in view of McIntosh teaches the device of claim 1. Gourlay ‘446 further teaches 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).
Regarding claim 19, Gourlay ‘446 in view of McIntosh teaches 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 McIntosh et al. (Publication No. US 2021/0402354 A1), as applied to claim 1 above, and further in view of Cotton et al. (Publication No. US 2012/0175319 A1), hereby referred to as “Cotton ‘319”.
Regarding claim 3, Gourlay ‘446 in view of McIntosh teaches the device of claim 1. Gourlay ‘446 in view of McIntosh 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 in view of McIntosh 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 McIntosh to incorporate the teachings of Cotton ‘319 and have the membrane filter of Gourlay ‘446 in view of McIntosh 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 in view of McIntosh teaches the device of claim 1. The combination of Gourlay ‘446 in view of McIntosh 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 in view of McIntosh 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 McIntosh to incorporate the teachings of Cotton ‘319 and have the membrane filter of Gourlay ‘446 in view of McIntosh 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 in view of McIntosh teaches the device of claim 1. The combination of Gourlay ‘446 in view of McIntosh 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 in view of McIntosh 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 McIntosh to incorporate the teachings of Cotton ‘319 and have the outer bag of Gourlay ‘446 in view of McIntosh 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 McIntosh et al. (Publication No. US 2021/0402354 A1), as applied to claim 1 above, and further in view of Ashitaka et al. (Publication No. US 2015/0232506 A1).
Regarding claim 4, Gourlay ‘446 in view of McIntosh teaches the device of claim 1. The combination of Gourlay ‘446 in view of McIntosh 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 in view of McIntosh 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 McIntosh to incorporate the teachings of Ashitaka and have the membrane filter of Gourlay ‘446 in view of McIntosh 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) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Gourlay (Patent No. US 9,636,446 B2) in view of McIntosh et al. (Publication No. US 2021/0402354 A1), as applied to claim 1 above, and further in view of Cotton et al. (Publication No. US 2021/0015988 A1), hereby referred to as “Cotton ‘988”).
Regarding claim 12, Gourlay ‘446 in view of McIntosh teaches the device of claim 1. The combination of Gourlay ‘446 in view of McIntosh 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 in view of McIntosh 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 in view of McIntosh to incorporate the teachings of Cotton ‘988 and have the outer bag of Gourlay ‘446 in view of McIntosh 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 McIntosh et al. (Publication No. US 2021/0402354 A1), as applied to claim 1 above, and further in view of Cotton et al. (Publication No. US 2012/0175319 A1), and Ashitaka et al. (Publication No. US 2015/0232506 A1).
Regarding claim 8, Gourlay ‘446 in view of McIntosh teaches 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 in view of McIntosh does not expressly teach an air flow rate of at least 20 L/m2.s.200Pa.
However, 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 with an air flow rate of at least 20 L/m2.s.200Pa 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 air flow rate 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 flow rate is the claimed range (Claim 6; specification; Paragraph 0056).
The modified combination of Gourlay ‘446 in view of McIntosh 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 McIntosh 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 McIntosh to incorporate the teachings of Cotton ‘319 and have the membrane filter of Gourlay ‘446 in view of McIntosh 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 McIntosh 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 McIntosh 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 McIntosh and Cotton ‘319 to incorporate the teachings of Ashitaka and have the membrane filter of Gourlay ‘446 in view of McIntosh 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 is rejected under 35 U.S.C. 103 as being unpatentable over Gourlay (Patent No. US 9,636,446 B2) in view of McIntosh et al. (Publication No. US 2021/0402354 A1), as applied to claim 1 above, and further in view of Gourlay (Publication No. US 2011/0272343 A1), hereby referred to as “Gourlay ‘343”.
Regarding claim 11, Gourlay ‘446 in view of McIntosh teaches the device of claim 1. The combination of Gourlay ‘446 in view of McIntosh 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 in view of McIntosh 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 in view of McIntosh to incorporate the teachings of Gourlay ‘343 and have the outer bag of Gourlay ‘446 in view of McIntosh 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 McIntosh et al. (Publication No. US 2021/0402354 A1), as applied to claim 1 above, and further in view of Bieberich (Publication No. US 2002/0058975 A1).
Regarding claim 18, Gourlay ‘446 in view of McIntosh the device of claim 1. Gourlay ‘446 in view of McIntosh 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 in view of McIntosh 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 in view of McIntosh to incorporate the teachings of Bieberich and have the superabsorbent polymer of Gourlay ‘446 in view of McIntosh 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 McIntosh and 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 McIntosh and 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).
Claim(s) 20 is 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).
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).
Conclusion
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
