DETAILED ACTION
For this Office action, Claims 1-9, 12-13, 15-16 and 18-25 are pending. Claims 24 and 25 are new, Claims 1-3 and 12-13 are withdrawn from consideration due to a previous restriction requirement, and Claims 10-11, 14 and 17 are canceled.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 26 February 2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claims 4-9, 15-16 and 18-23 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. Applicant has amended the claims in a manner that adds new limitations not addressed in the previous Office action, and applicant argues that the cited prior art of the previous Office action does not disclose the newly added limitations. Such limitations in particular require that the raised features be reinforcing raised features, wherein the plurality of reinforcing raised features provides mechanical support and improved structural integrity to the collapsible blood container in instant Claim 4 (upon which the remaining examined claims are dependent). The grounds of rejection are therefore withdrawn. Further search and consideration raise new grounds of rejection with a secondary reference that addresses these issues, wherein said grounds are detailed below. Since the arguments do not address these new grounds of rejection, they are considered moot and will not be addressed further at this time.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 25 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Newly filed Claim 25 recites a collapsible blood container comprising “one or more chambers in fluid communication with one another”, which is unclear on whether a plurality of chambers are required or only one (one or more). If only one chamber is required, as the claim recites, then the claim is unclear on how the one chamber can read on the “in fluid communication with one another” limitation. For purposes of this examination, the examiner will assume one fluid chamber is enough to read on the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4-7, 16, 17 and 19-25 are rejected under 35 U.S.C. 103 as being unpatentable over Dorian et al. (herein referred to as “Dorian”, US Pat Pub. 2014/0107562) in view of Manders et al. (herein referred to as “Manders”, US Pat Pub. 2004/0126880) and Terentiev, US Pat Pub. 2005/0117449.
Regarding instant Claim 4, Dorian discloses a reinforced silicone membrane (Figure 1E; Paragraph [0012]; Paragraph [0014]; Paragraph [0070]; membrane 27 made of silicone and reinforced with fibers/other materials) comprising: a silicone membrane having an area (Figure 1E; Paragraph [0070]; membrane 27 has a surface area), an average thickness of less than 100 x 10-6 M (Paragraph [0081]; membrane thickness may be around 50-100 microns), and a plurality of raised features on at least one side of the silicone membrane, each of the raised features comprising silicone (Figure 1E; Paragraph [0070]; see raised channels 28 extending from membrane 27 in cited figure) and having width of between 100 μm to 10000 μm oriented perpendicular to a height of between 20 μm to 5000 μm (Figure 1E; Paragraph [0061]; Paragraph [0070]; size and construction can range for fibers 12 from 400 to 2000 microns in diameter [both height and width], thus raised channels 28 would also be adjusted to the same height/width to accommodate for fibers 12), wherein the reinforced silicone membrane has a fluidic connection (Figure 6; Paragraph [0083]; system may incorporate port 92).
However, while the reference does disclose that a reservoir may be contained within the dressing that contains the reinforced silicone membrane (Paragraph [0010], see reservoir), Dorian is silent on the reinforced silicone membrane being part of a collapsible blood container. Dorian is further silent on providing a plurality of reinforcing raised features, wherein the plurality of reinforcing raised features provides mechanical support and improved structural integrity to the collapsible blood container.
Manders discloses sterilization, stabilization and preservation of functional biologics in the same field of endeavor as the instant application, as it solves the mutual problem of treating interacting with biochemical entities and biological materials (Abstract; Paragraph [0064]). Manders further discloses that collapsible silicone bags are suitable for containing sterilized and stabilized blood products (Paragraph [0064]).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention, since Dorian discloses material that interacts with blood and similar body fluids (Abstract; Paragraph [0002]; Paragraph [0056]), to modify the reinforced silicone membrane to comprise part of a collapsible blood container as taught by Manders because Manders discloses such silicone is suitable containing sterilized and stabilized blood products (Manders, Paragraph [0064]).
However, the combined references are further silent on providing a plurality of reinforcing raised features, wherein the plurality of reinforcing raised features provides mechanical support and improved structural integrity to the collapsible blood container.
Terentiev discloses a sterile fluid pumping or mixing system and related method in the same field of endeavor as the instant application, as it solves the mutual problem of providing a bag for the pumping of fluid, including blood (Figure 14; Paragraph [0082]; Paragraphs [0110]-[0111]). Terentiev further discloses structural reinforcing ribs (or raised features) on the bag that provide more support and rigidity without interfering with internal bag processes and fluid handling (Paragraph [0111]).
It would have been obvious to one or ordinary skill in the art at the time of the effective filing date of the invention to modify the raised features of Dorian to further include a plurality of reinforcing raised features, wherein the plurality of reinforcing raised features provides mechanical support and improved structural integrity to the collapsible blood container as taught by Terentiev because Terentiev discloses the reinforcing raised features (ribs) provide more support and rigidity without interfering with internal bag processes and fluid handling, such as those performed by the raised features of Dorian (Terentiev, Paragraph [0111]; Dorian, Figure 1E; Paragraph [0070]).
Regarding instant Claim 5, Claim 4, upon which Claim 5 is dependent, has been rejected above. The combined references further disclose wherein the plurality of reinforcing raised features covers less than 50% of the area of the at least one surface of the reinforced silicone membrane (Terentiev, Paragraph [0111]; Dorian, Figure 1D; Figure 1E; Paragraph [0070]; see total area of membrane 27 in Figure 1D).
Regarding instant Claim 6, Claim 4, upon which Claim 6 is dependent, has been rejected above. The combined references further disclose wherein each of the reinforcing raised features comprises a cross-section comprising a height of between 100 μm and 2500 μm and a width oriented perpendicular to the height greater than the width (Terentiev, Paragraph [0111]; Dorian, Figure 1E; Paragraph [0061]; Paragraph [0070]; size and construction can range for fibers 12 from 400 to 2000 microns in diameter [both height and length], thus raised channels 28 would also be adjusted to the same height/width to accommodate for fibers 12; see channel orientation wherein height is greater than width of channels 28).
Regarding instant Claim 7, Claim 6, upon which Claim 7 is dependent, has been rejected above. The combined references further disclose wherein the reinforcing raised feature comprises a pattern comprising a radius between 2 mm and 72 mm (Terentiev, Paragraph [0111]; Dorian, Figures 2A-2B; Paragraph [0075]; diameter of pattern is suggested as 3 inches or 1.5 inches/38.1 mm).
Regarding instant Claim 16, Claim 4, upon which Claim 16 is dependent, has been rejected above. Dorian further discloses wherein the average width is between 200 μm and 5000 μm (Figure 1E; Paragraph [0061]; Paragraph [0070]; size and construction can range for fibers 12 from 400 to 2000 microns in diameter [both height and width], thus raised channels 28 would also be adjusted to the same height/width to accommodate for fibers 12).
Regarding instant Claim 19, Claim 4, upon which Claim 19 is dependent, has been rejected above. The combined references further disclose wherein the plurality of reinforcing raised features comprises a uniform tiling pattern (Terentiev, Paragraph [0111]; Dorian, Figures 1D and 1E; see uniformity of the channels 28 on membrane 27).
Regarding instant Claim 20, Claim 19, upon which Claim 20 is dependent, has been rejected above. Dorian further discloses wherein the uniform tiling pattern comprises a square tiling (Figures 1D and 1E; Figure 5A; square configuration of the membrane and the raised feature).
Regarding instant Claim 21, Claim 4, upon which Claim 21 is dependent, has been rejected above. Dorian further discloses wherein the silicone membrane is cast (Paragraph [0011]; Paragraph [0012]; reference discloses a casting procedure wherein fibers are coated with silicone).
Regarding instant Claim 22, Claim 4, upon which Claim 22 is dependent, has been rejected above. The combined references further disclose wherein the plurality of reinforcing raised features comprises a first subset of reinforcing raised features disposed on a first surface of the silicone membrane and a second subset of reinforcing raised features disposed on a second side of the silicone membrane (Terentiev, Paragraph [0111]; Dorian, Figure 1E; Paragraph [0070]; Paragraph [0073]; multiple raised features throughout the width of the membrane 27).
Regarding instant Claim 23, Claim 22, upon which Claim 23 is dependent, has been rejected above. The combined references further discloses wherein the second subset of reinforcing raised features is different from the first raised feature (Terentiev, Paragraph [0111]; Dorian, Figure 1E; Paragraph [0070]; Paragraph [0073]; conduit 28 on the left of Figure 1E is different from conduit 28 on the right of Figure 1E).
Regarding instant Claim 24, Claim 4, upon which Claim 24 is dependent, has been rejected above. The combined references further disclose wherein the plurality of reinforcing raised features reduces tearing, splitting, or rupturing of the silicone membrane during use of the collapsible blood container (Terentiev, Paragraph [0111]; ribs provide structural reinforcement to prevent such loss of integrity).
Regarding instant Claim 25, Claim 4, upon which Claim 25 is dependent, has been rejected above. The combined references further disclose wherein the collapsible blood container comprises one or more chambers in fluid communication with one another (Dorian, Abstract; Figure 1A; Figure 1E; Paragraph [0059]; Paragraphs [0070]-[0072]; fluid channels 28 are in fluid communication with each other via fluid flow conduction).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Dorian et al. (herein referred to as “Dorian”, US Pat Pub. 2014/0107562) in view of Manders et al. (herein referred to as “Manders”, US Pat Pub. 2004/0126880) and Terentiev, US Pat Pub. 2005/0117449, as applied to claim 4 above, and further in view of Ahn et al. (herein referred to as “Ahn”, US Pat Pub. 2015/0231556).
Regarding instant Claim 8, Claim 4, upon which Claim 8 is dependent, has been rejected above. Dorian discusses permeability, but is silent on any value of permeability for the membrane.
Ahn discloses a method of manufacturing a silicone membrane in the same field of endeavor as Dorian, as it solves the mutual problem of providing silicone membranes (Abstract). Ahn further discloses that silicone membranes may have permeabilities of up to 302 GPU (wherein 1 GPU=1 ml/sec*cm2*mmHg; Paragraph [0006]; Paragraph [0124]).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the permeability of the membrane of Dorian to be at least 1.2x10-6 ml/sec*cm2*mmHg as taught by Ahn because Ahn discloses such permeabilities can be achieved with silicone membranes (Ahn, Paragraph [0006]; Paragraph [0124]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Dorian et al. (herein referred to as “Dorian”, US Pat Pub. 2014/0107562) in view of Manders et al. (herein referred to as “Manders”, US Pat Pub. 2004/0126880) and Terentiev, US Pat Pub. 2005/0117449, as applied to claim 4 above, and further in view of Yoshida et al. (herein referred to as “Yoshida”, US Pat Pub. 2012/0024156; found in IDS filed 08/18/2023).
Regarding instant Claim 9, Claim 4, upon which Claim 9 is dependent, has been rejected above. However, the combined references are silent on an oxygen depletion device.
Yoshida discloses a blood storage bag system and depletion devices with oxygen and carbon dioxide depletion capabilities in the same field of endeavor as Dorian, as it solves the mutual problem of providing silicone membranes with procedures involving blood (Abstract). Yoshida further discloses a silicone membrane comprised within an oxygen depletion device comprising an outer receptacle substantially impermeable to oxygen and an inner collapsible blood container, wherein the silicone membrane removes oxygen from the blood within the bag (Figure 1; Figure 4A; Paragraph [0026]; Paragraph [0062]; Paragraph [0063]; Paragraph [0066]; satchel made from silicone membrane is placed within blood bag 205 with laminated oxygen barrier 206).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the collapsible blood container of Dorian by placing it within the oxygen depletion device of Yoshida because Yoshida discloses such the silicone membrane will aid in scavenging the oxygen within said oxygen depletion device (Yoshida, Paragraph [0026]; Paragraph [0062]; Paragraph [0063]; Paragraph [0066]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Dorian et al. (herein referred to as “Dorian”, US Pat Pub. 2014/0107562) in view of Manders et al. (herein referred to as “Manders”, US Pat Pub. 2004/0126880) and Terentiev, US Pat Pub. 2005/0117449, as applied to claim 4 above, and further in view of Chu et al. (herein referred to as “Chu”, US Pat Pub. 2013/0175218).
Regarding instant Claim 15, Claim 4, upon which Claim 15 is dependent, has been rejected above. Dorian discloses a silicone membrane (Paragraph [0014]; Paragraph [0070]), but the reference is silent on polydimethyl siloxane (PDMS).
Chu discloses polymeric nanofibrous composite membranes for energy efficient energy distribution in the same field of endeavor as Dorian, as it solves the mutual problem of providing membranes composed of silicone (Paragraph [0056]). Chu further discloses that PDMS is an effective membrane comprised of silicone (Paragraph [0056]).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the silicone of Dorian to be PDMS as taught by Chu because Chu discloses such a membrane is an effective membrane comprised of silicone (Chu, Paragraph [0056]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Dorian et al. (herein referred to as “Dorian”, US Pat Pub. 2014/0107562) in view of Manders et al. (herein referred to as “Manders”, US Pat Pub. 2004/0126880) and Terentiev, US Pat Pub. 2005/0117449, as applied to claim 4 above, and further in view of Xie et al. (herein referred to as “Xie”, US Pat Pub. 2013/0324829).
Regarding instant Claim 18, Claim 4, upon which Claim 18 is dependent, has been rejected above. However, Dorian is silent on the membrane’s average peak load strength.
Xie discloses an adjustable suture in the same field of endeavor as Dorian, as it solves the mutual problem of providing silicone for clinical, surgical purposes (Abstract; Paragraph [0086]). Xie further discloses a peak load strength of about 0.18 N before failure (Paragraph [0086]).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the silicone membrane of Dorian by making the average peak load of around 0.18 N as taught by Xie because Xie discloses these loads are adequate for clinical purposes (Paragraph [0086]).
Conclusion
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/RICHARD C GURTOWSKI/Primary Examiner, Art Unit 1773 03/11/2026