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 .
Examiner Comment
It is noted that paragraph 97 of the specification of the current application describes Fig. 4(a) as a case in which the center line of the blood chamber 110 and the center line of the gas inflow/outflow port 112 are identical with each other and Fig. 4(b) is a case in which the center line of the blood chamber 110 and the center line of the gas inflow/outflow port 112 are orthogonal to each other. However, the term “centerline” is interpreted as “a real or imaginary line that is equidistant from the surface or sides of something.” (see “Centerline.” Merriam-Webster Dictionary, https://www.merriam-webster.com/dictionary/centerline. Accessed July 21, 2026). Taking into consideration the definition of center line (aka “centerline”), Fig. 4(a) shows the gas inflow/outflow port is disposed such that a center line of the gas inflow/outflow port is orthogonal to a center line of the blood chamber, as shown below. Please note that the centerlines are not perfectly centered but convey the general idea of where the center lines are considered.
Response to Amendment
The amendments to the specification and claims 1, 6, 10-12, and 15-19, as well as the cancellation of claim 13 are acknowledged.
The drawings were received on July 9, 2026. These drawings are unacceptable because they contain new matter in Figure 8, specifically a specific position of a pneumatic pressure pump that was not in the originally filed disclosure and consequently the drawings are not entered. Relatedly, a specification objection appears below to the specification amendments related to this drawing modification.
Response to Arguments
Applicant’s arguments that the amended drawings overcome the previous drawing objections regarding drawings not including specific reference signs are not persuasive, as the replacement drawings are not entered. However, if the drawings were not to include new matter and made the same modification regarding references 620 and 630, they would overcome the drawing objection.
Applicant’s arguments that the cancellation of claim 13 overcomes the previous drawing objection regarding the previous limitations of claim 13 is not persuasive, as those previous limitations of claim 13 now appear in claim 11. As such, that drawing objection is maintained below as the replacement drawings were not entered.
Applicant’s arguments that amendments overcome all previous 35 USC 112(b) rejections are not persuasive, as the rejection of claim 17 and its dependents regarding “an inlet valve” in line 7 is maintained, though all other 35 USC 112(b) rejections are overcome due to amendments to the claims. As such, all previous 35 USC 112(b) rejections except for claim 17-19 are withdrawn. However, additional new rejections appear regarding the most recent amendments.
Applicant’s arguments with respect to claim(s) 1 and Lim 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’s arguments regarding Johns and Kato are not persuasive, as Johns discloses the amendment requiring the gas inflow/outflow port is disposed such that a center line of the gas inflow/outflow port is orthogonal to a center line of the blood chamber (see annotated figure below).
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Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: connection valve 610, inlet valve 620, and outlet valve 630 as described in paragraph 132 of the specification. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “pneumatic pressure pump disposed in a connection pipe that connects the blood pump and the oxygenator and is configured to form vacuum in the blood pump by sucking the gas supplied to the blood pump” in claim 11 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The amendment filed July 9, 2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: the blood oxygenation system 1000’ as appears in paragraphs 125, 129-130, 132, 136, 140 along with the pump 400 disposed in the connection pipe described as schematically depicted in Figure 8, content of paragraph 125 .
Applicant is required to cancel the new matter in the reply to this Office Action.
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.
Claims 1-12 and 14-19 are 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.
Regarding claim 1, the limitation “the gas inflow/outflow port is disposed such that a center line of the gas inflow/outflow port is orthogonal to a center line of the blood chamber” renders the claim indefinite as the specification of the current claim describes Fig. 4(b) as having such a configuration (see Examiner comment above) when he common meaning of center line would have such a configuration shown in Fig. 4(a). It is unclear exactly how “center line” should be interpreted in the current application and as such, “center line” is interpreted using the definition explained above in the Examiner Comment section. It is also pointed out that what is shown in Fig. 4(b) below regarding the position of the blood chamber in comparison to the inflow/outflow port is shown in Lim et al. (KR 101882479) in Figure 2.
Claims 2-12 and 14-19 are rejected as dependents of claim 1.
Regarding claim 17, the limitation “an inlet valve” in line 7 renders the claim indefinite, as it is unclear whether this is the same or different than that of claim 1.
Claims 18-19 are rejected as dependents of claim 17.
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.
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.
Claim(s) 1-2, 4-6, and 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johns et al. (US 2019/0358375) in view of Kato et al. (US 6,123,519).
Regarding claim 1, Johns discloses a blood pump forcing blood to flow in one direction (see Figs. 1-3, par. 49-50), comprising: a blood chamber (see Fig. 3, blood 16 goes into pump apparatus) comprising an outer wall (see Fig. 3, outside wall like outer duct 11 in Fig. 2) configured to have a fluid inflow/outflow port formed at one end thereof (see Fig. 3, port above compression of main chamber to eject blood, which is like fluid port 15 in Fig. 2), wherein the inflow/outflow port is disposed such that a center line of the inflow/outflow port is orthogonal to a center line of the blood chamber (see annotated drawing below), and a pouch 200 inserted into the outer wall and configured to have both ends coupled to both ends of the outer wall, respectively (see Fig. 3); an inlet valve 23 for the blood pump coupled to one end of the blood chamber in a way that a fluid communicates therewith and configured to block a flow of blood to the blood chamber (see Fig. 3, par. 50); and an outlet valve 24 for the blood pump coupled to the other end of the blood chamber in a way that a fluid communicates therewith and configured to block a flow of blood from the blood chamber (see Fig. 3, par. 50).
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Johns does not disclose the fluid inflow/outflow port being a gas inflow/outflow port, though Johns discloses the pumping liquid can be any suitable non-toxic liquid such as saline solution, water or silicone oil (see par. 38).
Kato discloses it is well known for a fluid pump to use liquid, such as saline or water, or gas into and out of the pumping means to intermittently repeat inflow and outflow of the fluid (see col. 16, lines 61-64). Consequently, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the inflow/outflow port be a gas inflow/outflow port, Kato disclosing such a known alternative of the saline or water disclosed by Johns and using gas would predictably result in the inflow/outflow material to help with the pumping via providing gas into and out of the pouch.
Regarding claim 2, Johns and Kato disclose the limitation of claim 1, and further disclose in the blood chamber, pneumatic pressure is formed between the outer wall and the pouch by a gas that is introduced and discharged through the gas inflow/outflow port (see Johns, Fig. 3 and par. 30 and rejection of claim 1 above explaining how gas would be introduced and discharged through port).
Regarding claim 4, Johns and Kato disclose the limitations of claim 1, and further disclose wherein one side of the pouch is deformed by pneumatic pressure so that a flow of blood is formed (see Johns, Fig. 3 and par. 30 and rejection of claim 1 above explaining how gas would be introduced and discharged through port, affecting side of pouch).
Regarding claim 5, Johns and Kato disclose the limitations of claim 1, and Johns further discloses the pouch 200 is formed in a hollow form having an elastic restoring force (see Fig. 3, par. 50, flexible inner tube with pneumatic compression causing pumping of fluid so that there is ejection of blood from the pouch).
Regarding claim 6, Kato and Johns disclose the limitations of claim 1 and Johns discloses the inlet valve for the blood pump or the outlet valve for the blood pump further comprises: a valve outer wall having a gas inflow/outflow port formed at one end thereof (see Fig. 3, port with arrow going in, as with valve 23, or other port with arrow going out, as with valve 24, showing fluid flowing into or out of valve and port is on each outer wall of each valve); and a valve pouch inserted into the valve outer wall and configured to have both ends coupled to both ends of the valve outer wall, respectively (see Fig. 3, inside of valves that move to allow valve to open and close).
Regarding claim 8, Kato and Johns disclosed the limitations of claim 6, and Johns further discloses one side of the valve pouch is deformed by pneumatic pressure so that a flow of blood is blocked (see Fig. 3, par. 50).
Regarding claim 9, Kato and Johns disclosed the limitations of claim 6, and Johns further discloses the valve pouch is formed in a hollow form having an elastic restoring force (see Fig. 3, par. 11, 50).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johns in view of Kato as applied to claim 6 above, and further in view of Chmiel (US 4,008,710).
Regarding claim 7, Johns and Kato discloses the limitations of claim 6 but do not disclose an outward form of each of the valve outer wall and the valve pouch is a bent pipe shape.
Chmiel discloses a pump with an outlet valve bent shape having a pouch 14 and outer wall 10, wherein the outer wall 10 connects to an oxygenator (see Fig. 1; col. 3, lines 42-48). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the blood pump have the valve outer wall and valve pouch be a bent pipe shape, as disclosed by Chmiel, this shape being a well-known alternative for allowing for connection to an oxygenator, such connection shown as desirable by Johns (see par. 21, pump in ECMO, which would require oxygenator), and predictably resulting in valve allowing for inflow/outflow to help with pumping blood.
Claim(s) 1, 3, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lim et al. (KR 101882479). While a copy and translation of Lim has been provided by applicant, all citations to the Description section below are to the translation provided with the previous office action.
Regarding claim 1, Lim discloses a blood pump (see Figs. 2-4) forcing blood to flow in one direction (see par. 40), comprising: a blood chamber comprising an outer wall 100 configured to have a gas inflow/outflow port 130 formed at one end thereof and a pouch (see Figs. 2-3, par. 28 bag 200 shown in Fig. 3 is accommodated inside housing 100) inserted into the outer wall (see par. 28) and configured to have both ends coupled to both ends of the outer wall, respectively (see Figs. 2, 3; par. 29, 32, 38); an inlet valve 300 for a pump coupled to one end of the blood chamber in a way that a fluid communicates therewith and configured to block a flow of blood to the blood chamber (see par. 35, 41-42); and an outlet valve 400 for a pump coupled to the other end of the blood chamber in a way that a fluid communicates therewith and configured to block a flow of blood from the blood chamber (see oar. 35, 50-51).
Lim does not disclose in the embodiment discussed above, the gas inflow/outflow port is disposed such that a center line of the gas inflow/outflow port is orthogonal to a center line of the blood chamber.
Lim, however, discloses that it is well known in the prior art to have such a configuration (see Figs. 1a()-1(b) showing conduit causing pneumatic flow into a chamber having a center line that is orthogonal to the chamber centerline). Consequently, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have such a configuration, Lim showing this is well known and as it would predictably result in supplying an inflow/outflow of gas into and out from the chamber for pumping. Furthermore, Lim does not teach away from this configuration of the prior art (see par. 8), as Lim discusses the problems relate to the leaflets at the ends of the chamber.
Regarding claim 3, Lim discloses the blood chamber, an outward form of each of the outer wall and the pouch is a bent pipe shape (see Fig. 2).
Regarding claim 10, Lim discloses a connection unit 120, 110 configured to have both ends coupled to the blood chamber and the inlet valve for a pump or the outlet valve for a pump (see Figs. 2-3), respectively, and to have an internal diameter that is increased from an end of the connection unit coupled to the inlet valve for a pump or the outlet valve for a pump toward an end of the connection unit coupled to the blood chamber (see Figs. 2-3).
Allowable Subject Matter
Claims 11-12 and 14-19 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. Please note, that there are also drawing objections that affect the allowance of this application.
The following is a statement of reasons for the indication of allowable subject matter for claims 11 and its dependents: the closest prior art found is Johns, Kato, Brady et al. (US 2011/0129389), Fischel (US 3,877,843), and Orr (US 2009/0137940), which do not disclose a connection pipe that connects the blood pump and the oxygenator and is configured to form vacuum in the blood pump by sucking the gas supplied to the blood pump, or oxygen moved from the pressure tank to the blood pump and form the blood pump to the oxygenator through the connection pipe. In applicant’s invention, oxygen is moved throughout the system, helping to pump the blood pump and oxygenate via the oxygenator via a connection between the blood pump and the oxygenator. None of the prior art found has such a connection. Furthermore, while Mechanika (GB 1,046,098) discloses supplying oxygen via the same tank to help pump the blood pumps and supply and oxygenator with blood, these connections to the blood pumps and the oxygenator are separate connections that would not allow for oxygen to move between the blood pump and the oxygenator.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ARIANA ZIMBOUSKI whose telephone number is (303)297-4665. The examiner can normally be reached 8:30 - 5:00 PST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, REBECCA E EISENBERG can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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