DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is response to communications filed February 11, 2026.
Status of Claims
1. Claims 1-2, 4-13 and 15-21 are pending and currently under consideration for patentability.
Claims 3 and 14 are cancelled as of the February 11, 2026 amendments.
Response to Arguments
2. Applicant's arguments filed February 11, 2026 have been fully considered but they are not persuasive.
Applicant argues that the cited Figures and passages of Lindsay do not teach a fluid connection element, an energy connection element, or a data connection element, as required by the claims - instead, one having ordinary skill in the art would recognize that the cited Figures and passages of Lindsay only teach a mechanical coupling; however, examiner respectfully disagrees. Looking to Lindsay at page 16, line 12 to page 17, line 7 cited by examiner in the Office action, and repeated by applicant on page 7 of the arguments filed February 11, 2026, “a fluid connection element” is clearly disclosed and/or suggested to one having ordinary skill in the art. Applicant argues that Lindsay merely teaches a mechanical coupling; however, it is clear from the cited passage of Lindsay that the “further embodiment of the carrier 82 has a top surface 129 of the attachment plate 128 which may include a channel 132 for laterally receiving and securely retaining a disk or an adapter flange 125 that may be bonded, snapped, or otherwise attached to an upper blood handling apparatus, such as a blood reservoir 20 (which is not shown for clarity).” Accordingly, the carrier attachment plate and securely retained blood reservoir provide a clear fluid connection element for a “lower blood handling apparatus, such as an oxygenator.” In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “a fluid tight and sealed connection between the blood reservoir and the oxygenator”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The “fluid tight and sealed connection between the blood reservoir and the oxygenator” recited by examiner was merely a statement of obviousness motivation, that one having ordinary skill in the art would make, in view of the cited Figures and passages. In order for the fluid connection element, energy connection element, and/or data connection element to impart further patentable weight (such as fluid tight/sealed connection, etc.), examiner recommends the inclusion of additional structural and/or functional language to the claims; as long as the prior art discloses an element fully capable of providing a fluid, energy or data connection in any way, then it reads on the claim. Accordingly, the grounds of rejection applied to previous claims 3 and 14 (now cancelled and amended into claims 1 and 13), is maintained herein.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
3. Claims 1, 2, 4, 5, 9, 10, 13 and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Lindsay (WO 00/47266) in view of Olsen et al. (WO 2005/065744 A1) in view of Buckholtz (US 5,147,186).
4. With regard to claim 1, Lindsay discloses connection assembly (various mounting and interfacing structures between stand assembly/mast, 90 and heart lung machine, 91; Figs. 2A, 4) configured to facilitate connecting at least one heart lung machine (HLM) component (blood reservoir, 20; blood oxygenator, 32; separate cardiotomy reservoir, 158; Fig. 8B) to an HLM base (heart lung machine, 91; abstract; page 4, lines 14-23), the connection assembly comprising: a mounting bracket (mounting bracket, 92 with integral mounting arm (unnumbered) having clamp, 96) comprising a connection interface (at clamp, 96) configured to facilitate coupling the connection assembly to at least one of the HLM base (91) and a mast (90) of the HLM, wherein the mast (90) is coupled to the HLM base (91; Figs. 2A, 4, 8B; page 8, lines 15-21); a component connector (carrier, 82) configured to facilitate removably connecting an HLM component (such as 20) to the HLM base (91; Figs. 5, 6A; page 8, lines 5-21; page 18, line 6-15; page 8, line 22 – page 21, line 27); and the HLM component includes a pump (centrifugal pump, 148; Fig. 8B; page 8, line 22 – page 21, line 27).
Lindsay discloses that the connection interface (96) is a clamp including a mast inert (90) disposed within the clamp arms of the mounting bracket, fully capable of swiveling via clamp repositioning (Figs. 2A, 4, 8B; page 8, lines 15-21); suggests the use of a hoop clamp (159) for mounting a reservoir (158) to the mast (90) where the mast is inserted within a hoop of the reservoir bracket hoop clamp (Fig. 8B; page 19, lines 19-26); suggests the use of hinged mounting brackets for repositioning (see circled structures of Annotated Figures above); and suggests the use of hinges (134) for securing a soft reservoir (Fig. 8B; page 19, line 11-19); however, Lindsay fails to explicitly disclose that the connection interface includes swiveling mast insert disposed within an aperture defined though the mounting bracket.
Olsen discloses a disposable, integrated, extracorporeal blood circuit (abstract) including a connection assembly (reusable circuit holder, 300; Fig. 6) comprising: a mounting bracket (mast arm assembly, 306, support arm assembly 330, and electronics arm assembly, 314) comprising a connection interface (shaft collar, 304 and 316) including a swiveling mast insert (mast, 302) disposed within an aperture (of collars 304, 316) defined through the mounting bracket (306, 314, 330) and configured to facilitate coupling the connection assembly (330) to the medical device components (page 24, line 10 – page 24, line 8; page 25, lines 1-13).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the connection assembly disclosed by Lindsay to instead utilize a swiveling mast insert disposed within an aperture through the mounting bracket, similar to that disclosed by Olsen, in order to allow for simple vertical and rotational positioning and/or repositioning of mounting brackets to be fixed at selected/optimal positions during the procedure, as suggested by Olsen on page 23, lines 10-27.
Further, while Lindsay discloses that the HLM component includes a pump (centrifugal pump, 148; Fig. 8B), Lindsay is silent in regard to the pump having an actuator control unit (ACU) directly connected to the pump, wherein the ACU is configured to control the pump.
However, Olsen discloses that the HLM component includes a centrifugal blood pump (150) that is electrically connected to and controlled by an ACU (a Bio-Console® drive console; not shown; page 15, lines 4-7). While Olsen fails to explicitly disclose a direct connection between the ACU and the pump (150), Olsen states that exemplary blood pump drive systems are disclosed, for example, in Buckholtz (US 5,147,186; page 15, lines 7-8). Buckholtz discloses a blood pump drive system (abstract; Figs. 1-4) comprising a pump (kinetic pump, 10) having an actuator control unit (pump control console, 12 having console wall, 20) directly connected to the pump (10 via receiver 14 and pump motor shaft, 52), wherein the ACU (20) is configured to control the pump (10; col. 2, lines 12-21; col. 2, line 55 – col. 3, line 53).
Accordingly, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the HLM pump component disclosed by Lindsay to include an actuator control unit directly connected to and controlling the pump, similar to that disclosed by Olsen in view of Buckholtz, in order to provide drive control to the pump, as suggested by Olsen on page 15, lines 4-7, while offering a pump control console which provides variable speed motor control over a wide range, as suggested by Buckholtz on page 5, lines 42-44.
As a final matter, while Lindsay is silent in regard to the component connector (82) of the Figures 2 through 6A embodiment, Lindsay discloses, in a separate component connector (82) for connection to an oxygenator (32; Figs. 6B-6E, 7A, 7B) which comprises a fluid connection element (attachment plate, 128 having channel, 132 for receiving and securely retaining the stem of the oxygenator; page 15, line 22 – page 17, line 7).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the blood reservoir component connector disclosed by Lindsay in view of Olsen and Buckholtz to further include a fluid connection element, similar to that disclosed by Lindsay in the oxygenator connection element carrier embodiments, in order to provide a component carrier that allows for fluid tight and sealed connection between the blood reservoir and the oxygenator, as suggested by Lindsay on page 16, line 12 to pate 17, line 7.
5. With regard to claim 13, Lindsay discloses heart lung machine (HLM; abstract; page 4, lines 14-23), comprising: an HLM base (91 ; Fig. 8B); and a connection assembly (various mounting and interfacing structures between stand assembly/mast, 90 and heart lung machine, 91; Figs. 2A, 4) coupled to at least one of the HLM base (91) and a mast (90) that is coupled to the HLM base (91; Fig. 8B), and configured to facilitate connecting an HLM component (blood reservoir, 20; blood oxygenator, 32; separate cardiotomy reservoir, 158; Fig. 8B) to the HLM base (91), the connection assembly comprising: a mounting bracket (92 with integral mounting arm (unnumbered) having 96) comprising a connection interface (96) configured to facilitate coupling the connection assembly to the at least one of the HLM base (91) and the mast (90) that is coupled to the HLM base (91; Figs. 2A, 4, 8B; page 8, lines 15-21); a component connector (82) configured to facilitate removably connecting the HLM component (such as 20) to the HLM base (91; Figs. 5, 6A; page 8, lines 5-21; page 18, line 6-15; page 8, line 22 – page 21, line 27); and the HLM component includes a pump (centrifugal pump, 148; Fig. 8B; page 8, line 22 – page 21, line 27).
Lindsay discloses that the connection interface (96) is a clamp including a mast inert (90) disposed within the clamp arms of the mounting bracket, fully capable of swiveling via clamp repositioning (Figs. 2A, 4, 8B; page 8, lines 15-21); suggests the use of a hoop clamp (159) for mounting a reservoir (158) to the mast (90) where the mast is inserted within a hoop of the reservoir bracket hoop clamp (Fig. 8B; page 19, lines 19-26); suggests the use of hinged mounting brackets for repositioning (see Annotated Figures above); and suggests the use of hinges (134) for securing a soft reservoir (Fig. 8B; page 19, line 11-19); however, Lindsay fails to explicitly disclose that the connection interface includes swiveling mast insert disposed within an aperture defined though the mounting bracket.
Olsen discloses a disposable, integrated, extracorporeal blood circuit (abstract) including a connection assembly (reusable circuit holder, 300; Fig. 6) comprising: a mounting bracket (mast arm assembly, 306, support arm assembly 330, and electronics arm assembly, 314) comprising a connection interface (shaft collar, 304 and 316) including a swiveling mast insert (mast, 302) disposed within an aperture (of collars 304, 316) defined through the mounting bracket (306, 314, 330) and configured to facilitate coupling the connection assembly (330) to the medical device components (page 24, line 10 – page 24, line 8; page 25, lines 1-13).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the connection assembly disclosed by Lindsay to instead utilize a swiveling mast insert disposed within an aperture through the mounting bracket, similar to that disclosed by Olsen, in order to allow for simple vertical and rotational positioning and/or repositioning of mounting brackets to be fixed at selected/optimal positions during the procedure, as suggested by Olsen on page 23, lines 10-27.
Further, while Lindsay discloses that the HLM component includes a pump (centrifugal pump, 148; Fig. 8B), Lindsay is silent in regard to the pump having an actuator control unit (ACU) directly connected to the pump, wherein the ACU is configured to control the pump.
However, Olsen discloses that the HLM component includes a centrifugal blood pump (150) that is electrically connected to and controlled by an ACU (a Bio-Console® drive console; not shown; page 15, lines 4-7). While Olsen fails to explicitly disclose a direct connection between the ACU and the pump (150), Olsen states that exemplary blood pump drive systems are disclosed, for example, in Buckholtz (US 5,147,186; page 15, lines 7-8). Buckholtz discloses a blood pump drive system (abstract; Figs. 1-4) comprising a pump (kinetic pump, 10) having an actuator control unit (pump control console, 12 having console wall, 20) directly connected to the pump (10 via receiver 14 and pump motor shaft, 52), wherein the ACU (20) is configured to control the pump (10; col. 2, lines 12-21; col. 2, line 55 – col. 3, line 53).
Accordingly, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the HLM pump component disclosed by Lindsay to include an actuator control unit directly connected to and controlling the pump, similar to that disclosed by Olsen in view of Buckholtz, in order to provide drive control to the pump, as suggested by Olsen on page 15, lines 4-7, while offering a pump control console which provides variable speed motor control over a wide range, as suggested by Buckholtz on page 5, lines 42-44.
As a final matter, while Lindsay is silent in regard to the component connector (82) of the Figures 2 through 6A embodiment, Lindsay discloses, in a separate component connector (82) for connection to an oxygenator (32; Figs. 6B-6E, 7A, 7B) which comprises a fluid connection element (attachment plate, 128 having channel, 132 for receiving and securely retaining the stem of the oxygenator; page 15, line 22 – page 17, line 7).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the blood reservoir component connector disclosed by Lindsay in view of Olsen and Buckholtz to further include a fluid connection element, similar to that disclosed by Lindsay in the oxygenator connection element carrier embodiments, in order to provide a component carrier that allows for fluid tight and sealed connection between the blood reservoir and the oxygenator, as suggested by Lindsay on page 16, line 12 to pate 17, line 7.
6. With regard to claim 2, Lindsay discloses that the connection interface further comprises a quick-connect mast holder (such as clamps, 96; Fig. 2A, 4; page 8, lines 15-21; page 19, line 11-19).
7. With regard to claims 4 and 15, Lindsay discloses that the component connector (82) further comprising an engagement mechanism (two flanges, 126; Fig. 6A; page 18, lines 6-15).
8. With regard to claims 5 and 16, Lindsay further discloses a component support (attachment plate, 128; Figs. 5, 6A), the component support (128) comprising: a component mount (retention peg, 130 and substantially vertical mounting plate, 124; page 15, lines 22-29) configured to be coupled to the HLM component (20; Figs. 4, 8B); and a support arm (connected to clamp, 96) coupled, at a first end, to the component mount (130, 124, via 128), and extending away from the component mount (130, 124), wherein a second end of the support arm (of 96) is configured to be releasably engaged by the engagement mechanism (126) of the component connector (82; page 18, lines 6-15; via slidable engagement).
9. With regard to claims 9, 10 and 19, Lindsay further discloses an additional component connector (hoop clamp, 159, oxygenator carrier, 82; additional unlabeled carriers and clamps; Figs. 6A-6E, 7A, 7B, 8B, 9) configured to facilitate removably connecting an additional HLM component to the HLM base (91); and wherein the connection assembly is configured to facilitate connecting a plurality of HLM components, the plurality of HLM components comprising at least one of a reservoir (cardiotomy reservoir, 158), and an oxygenator (32; Fig. 8B; page 8, line 22 – page 21, line 27).
10. With regard to claim 18, while Lindsay is silent in regard to the component support (128) of the Figures 2 through 6A embodiment, Lindsay discloses, in a separate component support (128) for connection to an oxygenator (32; Figs. 6B-6E, 7A, 7B) which comprises a fluid connection element (attachment plate, 128 having channel, 132 for receiving and securely retaining the stem of the oxygenator; page 15, line 22 – page 17, line 7).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the blood reservoir component support disclosed by Lindsay in view of Olsen and Buckholtz to further include a fluid connection element, similar to that disclosed by Lindsay in the oxygenator connection element carrier embodiments, in order to provide a component carrier that allows for fluid tight, supported and sealed connection between the blood reservoir and the oxygenator, as suggested by Lindsay on page 16, line 12 to pate 17, line 7.
11. Claims 6-8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Lindsay in view of Olsen in view of Buckholtz, as applied to claims 5 and 16 above, and further in view of Brennan et al. (US PGPUB 2015/0144514).
12. With regard to claims 6, 8 and 17, Lindsay, Olsen and Buckholtz are silent in regard to the component support further comprising one or more illuminating elements configured to illuminate at least a portion of the HLM component; and wherein the one or more illuminating elements comprising at least one of a light emitting diode (LED) and a fiber-optic outlet.
However, Brennan discloses ophthalmic surgical systems, methods and devices (abstract; Figs. 1A-1F) comprising a component support (surgical tray, 10) configured for supporting and connecting medical devices and components (such as an infusion reservoir) to a tray base (104; [0062]); wherein the infusion reservoir support includes an illuminating element (light, such as LED) to illuminate fill level of the reservoir for tracking during use ([0095]; [0116]; [0159]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the component support disclosed by Lindsay in view of Olsen and Buckholtz to include an LED to illuminate at least a portion of the HLM component, similar to that disclosed by Brennan, in order to illuminate the fill level of the reservoir for tracking during use, and assisting in the reduction to the strain in the practitioner’s eyes during use, as suggested by Brennan in paragraph [0095].
13. With regard to claim 7, while Lindsay is silent in regard to the component support (128) of the Figures 2 through 6A embodiment, Lindsay discloses, in a separate component support (128) for connection to an oxygenator (32; Figs. 6B-6E, 7A, 7B) which comprises a fluid connection element (attachment plate, 128 having channel, 132 for receiving and securely retaining the stem of the oxygenator; page 15, line 22 – page 17, line 7).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the blood reservoir component support disclosed by Lindsay in view of Olsen and Brennan to further include a fluid connection element, similar to that disclosed by Lindsay in the oxygenator connection element carrier embodiments, in order to provide a component carrier that allows for fluid tight, supported and sealed connection between the blood reservoir and the oxygenator, as suggested by Lindsay on page 16, line 12 to pate 17, line 7.
14. Claims 11-12 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Lindsay in view of Olsen in view of Buckholtz, as applied to claims 10 and 19 above, and further in view of Al-Ali et al. (US PGPUB 2015/0097701).
15. With regard to claims 11-12 and 20-21, Lindsay, Olsen and Buckholtz are silent in regard to the plurality of HLM components comprising a sensor hub, the sensor hub comprising a plurality of hub connection elements, the plurality of hub connection elements comprising fluid connection elements and/or data connection elements (claims 11 and 20); and that the plurality of connection elements comprising at least one of a temperature sensor interface, a pressure sensor interface, a level sensor interface, and a bubble sensor interface (claims 12 and 21).
However, Al-Ali discloses a system (200) for displaying medical monitoring data (abstract) comprising a sensor hub (monitoring hub, 100; Figs. 2, 10, 11A, 11B, 18), the sensor hub (100) comprising a plurality of hub connection elements (serial data ports, 210; channel ports, 212; channel inputs, 1000), the plurality of hub connection elements comprising fluid connection elements and/or data connection elements ([0008]; [0077] [0093]; Fig. 2); wherein the plurality of connection elements comprising at least one of a temperature sensor interface ([0011]) and a pressure sensor interface ([0034]; [0056]; [0071]; [0075]; [0126]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the HLM components disclosed by Lindsay in view of Olsen and Buckholtz to include a sensor hub for connection to a plurality of different sensors, similar to that disclosed by Al-Ali, in order to provide a hub which receives data from a portable patient monitor in real-time, allowing for continuous patient monitoring of any desired physiological parameter during use of the HLM, as suggested by Al-Ali in paragraph [0056].
Conclusion
16. 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.
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached on (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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