DETAILED ACTION
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 1-4 and 7 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stewart (US 6882797) in view of Logan (US 20020073715).
With respect to claim 1, Stewart discloses a bag assembly for use with a heat exchanger. The bag assembly includes a first flexible bag (Figure 7:16) comprised of one or more sheets of polymeric film that are sealed around a first end and a second end to bound a first compartment. A first inlet port (Figure 7:26) and a first outlet port (Figure 7:28) are coupled to the first bag so as to communicate with the first compartment. A first partition projects into the first compartment between the first inlet port and the first outlet port so that fluid traveling between the first inlet and outlet ports must travel around the first partition. The second flexible bag (Figure 7:16a) is also formed using one or more sheets sealed around a first end and an opposing second end to create a second compartment. A second inlet port (Figure 7:26A) and a second outlet port (Figure 7:28a) are coupled to the second bag, such that the first outlet port is connected to the second inlet port via a first fluid line (Figure 7:200). This is taught in column 5, line 15 to column 6, line 2.
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Stewart, however, does not appear to expressly teach that a drain port is provided in the first fluid line.
Logan discloses a condensation plate comprising a plate having a channel in thermal communication with a cooling source (Figure 2:14). Condensate obtained from cooled gases passes through the channel (see Fig. 3A) and may be removed using a drain (Figure 1A:35). This is taught in paragraphs [0012]-[0017].
At the time of the invention, it would have been obvious to provide the Stewart first fluid line with a drain port. Logan teaches that it is often necessary to remove unwanted components from biological fluid during a heating/cooling operation, and those of ordinary skill would have expected a drain port to operate according to known principles. The provision of an additional outlet/drain port would have provided an expected, cumulative and routine effect. It is prima facie obvious to apply a known technique (here, a drain port) to a known device ready for improvement to yield predictable results. See MPEP 2143.
With respect to claims 2-4, Stewart and Logan disclose the combination as described above. Steward shows in Fig. 7 that the first partition extends into the first compartment from a first end of the first bag and that a second partition projects into the first compartment and is separated from the first partition. Stewart teaches that the partitions may be made by heat sealing the first and second sheets.
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With respect to claim 7, Stewart and Logan disclose the combination as described above. The first bag of Stewart includes a fluid path that extends from the first inlet to the first outlet, such that the fluid path has a sinusoidal or serpentine configuration.
Claims 5 and 6 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stewart (US 6882797) in view of Logan (US 20020073715) as applied to claim 4, and further in view of Schmidt (US 7232457).
Stewart and Logan disclose the combination as described above, however do not clearly show a third partition projecting into the first compartment, such that second and third partitions extend from a second end of the first bag.
Schmidt discloses a bag assembly for use with a heat exchanger. The bag assembly includes a flexible bag (Figure 1:10) comprised of one or more sheets of polymeric material having a first end and an opposing second that bounds a compartment. The one or more sheet is secured to a second sheet of polymeric film so that the compartment is bounded between the first sheet and the second sheet (“The fluid container is made of two or more sheets of thermally conductive plastic film material. The sheets of plastic film material are bonded or otherwise joined in a pattern which creates a fluid channel between the sheets”). An inlet port (Figure 2:26) and an outlet port (Figure 2:28) are coupled with the flexible bag so as to communicate with the compartment, and a first partition projects into the compartment between the inlet port and the outlet port so that fluid traveling between the inlet port and the outlet port must travel around the first partition. This is shown in Figs 1 and 3. Schmidt depicts that the first partition extends into the compartment from the first end of the bag and that second and third partitions extend into the compartment from the second end of the bag.
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Before the effective filing date of the claimed invention, it would have been obvious to modify the Stewart partitions to include second and third partitions that extend from the second end of the first compartment. Schmidt shows how this is a functionally equivalent strategy for creating a sinusoidal/serpentine flow pattern designed to increase the residence time and improve thermal transfer. A mere change in shape or design that does not substantially affect device operation is considered to be prima facie obvious. See MPEP 2144.04.
Claim 9 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stewart (US 6882797) in view of Logan (US 20020073715) as applied to claim 1, and further in view of Kuzyk (US 7722839).
Stewart and Logan disclose the combination as described above. Stewart further teaches a heat exchanger for processing the first bag, wherein a portion of the first bag is disposed against a side face of the heat exchanger body. Stewart shows that the heat exchanger body (Figure 1:10) includes a first side face and an opposing second side face for receiving the bag. Stewart, however, teaches that the heat exchanger utilizes an electric heater and therefore does not disclose a fluid channel extending between an inlet port and an outlet port.
Kuzyk discloses a heat exchanger system comprising a heat exchanger having a body (Figure 4:30). The body bounds a fluid channel (Figure 3:30a, 30b) that extends between an inlet port (Figure 3:32) and an outlet port (Figure 3:34). The fluid channel is configured to heat or cool a bag assembly (Figure 4:21) supported by the body. This is taught in column 2, line 66 to column 5, line 24.
At the time of the invention, it would have been obvious to use a heated or cooled fluid flowing through a fluid channel to heat/cool the bag assembly of Stewart. Kuzyk teaches that the temperature of fluid flowing through the fluid channel is effectively maintained using a heater 60, and that the fluid channel may directly contact and promote mixing within the bag assembly (“As heated fluid flows through the bladder, heat is transferred through the bladder wall to the plasma bag to thaw the biological material. The bladder wall expands against the plasma bag as the bladder fills with fluid, and contracts from the plasma bag as the bladder is drained. The expansion and contraction of the bladder wall agitates the plasma bag and biological material to accelerate the thawing process”).
Claims 10-15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stewart (US 6882797) in view of Logan (US 20020073715) and Kuzyk (US 7722839) as applied to claim 9, and further in view of Watanabe (US 5057429).
With respect to claim 10, Stewart, Logan and Kuzyk disclose the combination as described above, however Stewart does not expressly show that a plurality of openings extend transversely through a perimeter edge of the flexible bag, such that the openings interact with catches formed on the body of the heat exchanger.
Watanabe discloses a bag assembly for processing biological fluids. The assembly includes a flexible bag comprised of one or more sheets (Figure 3A:10) of polymeric material, wherein a first sheet overlays a second sheet to create a compartment. The bag includes at least one inlet port (Figure 2:4) and one outlet port (Figure 2:2). Watanabe further shows that the flexible bag includes a plurality of openings (Figure 2:7) that transversely extend through a perimeter edge of the bag in order to interact with catches (Figure 2:60) that project from a surface of a support body.
At the time of the invention, it would have been obvious to provide the Stewart bag assembly with a plurality of openings that interface with catches formed on a heat exchanger support surface. Watanabe shows how this is an effective and simple mechanism to secure and hold a bag in a correct orientation during processing (“the plastic sheet is formed with holes 7 at four corners for securing when rotation or shaking is effectuated”). As evidenced by Watanabe, openings may be formed around the perimeter seal of a bag using standard fabrication techniques.
With respect to claim 11, Stewart, Logan, Kuzyk and Watanabe disclose the combination as described above. Stewart teaches the use of silicone rubber insulated portions and thin film conductive heaters in at least column 3, lines 49-54.
With respect to claim 12, Stewart, Logan, Kuzyk and Watanabe disclose the combination as described above. The Watanabe openings 7 do not communicate with the compartment 3,5 of the flexible bag.
With respect to claim 13, Stewart, Logan, Kuzyk and Watanabe disclose the combination as described above. Watanabe shows that the inlet and outlet ports that extend through the perimeter edge of the bag.
With respect to claims 14 and 15, Stewart, Logan, Kuzyk and Watanabe disclose the combination as described above. Watanabe further shows that a portion of the perimeter edge of the bag is sloped toward the inlet and outlet ports 4, and that this portion of the perimeter edge has a roughly V-shape.
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Those of ordinary skill would have considered modifying the shape and pattern of the sealed perimeter of Stewart’s bag in accordance with the design shown by Watanabe. For example, those of ordinary skill would have recognized that the characteristics of the perimeter define the shape of the chamber, and that the shape of the chamber affects how the chamber is operated (e.g., the shape of the perimeter dictates how fluid moves through the chamber, a V-shaped funnel would direct fluid to the inlet/outlet). Alternatively, it is noted that mere changes in shape that affect device operation in a predictable way are considered to be prima facie obvious. See MPEP 2144.04.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7 and 9-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,711,233.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of U.S. Patent No. 10,711,233 (especially claims 1 and 6-8) include limitations drawn to
A bag assembly for use with a heat exchanger, the bag assembly comprising:
a first flexible bag comprised of one or more sheets of polymeric material, the first bag having a first end and an opposing second end that bounds a first compartment, wherein the one or more sheets of polymeric material comprise a first sheet of polymeric film overlaying and secured to a second sheet of polymeric film so that the first compartment is bounded between the first sheet and the second sheet;
a first inlet port and a first outlet port, being coupled with the first bag so as to communicate with the first compartment;
a first partition projecting into the first compartment between the first inlet port and the first outlet port so that fluid traveling between the first inlet port and the first outlet port must travel around the first partition,
a second flexible bag comprised of one or more sheets of polymeric material, the second bag having a first end and an opposing second end that bounds a second compartment;
a second inlet port and a second outlet port, being coupled with the second bag so as to communicate with the second compartment, and the first outlet port being connected to the second inlet port through a first fluid line;
a drain port coupled to the first fluid line connected between the first outlet port and the second inlet port.
Claims 1-7 and 9-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,012,579.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of U.S. Patent No. 12,012,579 (especially claims 1 and 5-9) include limitations drawn to
A bag assembly for use with a heat exchanger, the bag assembly comprising:
a first flexible bag comprised of one or more sheets of polymeric material, the first bag having a first end and an opposing second end that bounds a first compartment, wherein the one or more sheets of polymeric material comprise a first sheet of polymeric film overlaying and secured to a second sheet of polymeric film so that the first compartment is bounded between the first sheet and the second sheet;
a first inlet port and a first outlet port, being coupled with the first bag so as to communicate with the first compartment;
a first partition projecting into the first compartment between the first inlet port and the first outlet port so that fluid traveling between the first inlet port and the first outlet port must travel around the first partition,
a second flexible bag comprised of one or more sheets of polymeric material, the second bag having a first end and an opposing second end that bounds a second compartment;
a second inlet port and a second outlet port, being coupled with the second bag so as to communicate with the second compartment, and the first outlet port being connected to the second inlet port through a first fluid line
a drain port coupled to the first fluid line connected between the first outlet port and the second inlet port.
Response to Arguments
Applicant's arguments filed 09 March 2026 have been fully considered but they are not persuasive.
Applicant argues that modifying Stewart to include a drain port would change its principle of operation. Adding a drain port to Stewart, however, would not alter or affect the fundamental strategy regarding how the Stewart device is operated. The drain port would only be used when necessary or desirable, and would function as an additional fluid pathway to carry condensate or any other liquid. The provision of an optional/alternative flow path would not frustrate Stewart’s operation as a heating unit. The drain port would function in a simple and predictable manner. It is prima facie obvious to apply a known technique (here, a drain port) to a known device ready for improvement to yield predictable results. See MPEP 2143.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN ANDREW BOWERS whose telephone number is (571)272-8613. The examiner can normally be reached M-F 7am-5pm.
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/NATHAN A BOWERS/Primary Examiner, Art Unit 1799