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 July 2, 2026.
Continued Examination Under 37 CFR 1.114
1. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 2, 2026 has been entered.
Status of Claims
2. Claims 1-2, 4-13, 15-21 and 23-24 are pending and currently under consideration for patentability.
Claims 23 and 24 are newly presented as of the July 2, 2026 amendments.
Response to Arguments
3. Applicant’s arguments with respect to claim(s) 1-2, 4-13, 15-21 and 23-24 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.
Kollar et al. (US PGPUB 2003/0135152 A1) is introduced as the primary reference of rejection, in view of applicant’s claim amendments.
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.
4. Claims 1, 2, 4-12 and 23 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.
In lines 7 and 11 of claims 1, and lines 2-3 of claim 23 recite the limitation "the HLM". There is insufficient antecedent basis for this limitation in the claim. Claim 1 provides antecedent basis for “an HLM component” and “an HLM base” – but not specifically “an HLM”. This creates confusion as to whether the HLM component or HLM base is being referred to. For the purposes of examination, each instance of the term “the HLM” will be interpreted as “the HLM base.”
Claims 2, 4-12 are rejected for depending from rejected base claim 1.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
5. Claim(s) 1, 4, 5, 9-13, 15, 16, 19-21, and 23-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kollar et al. (US PGPUB 2003/0135152 A1).
6. With regard to claim 1, Kollar discloses a connection assembly (perfusion system, 1) configured to facilitate connecting at least one heart lung machine (HLM) component (disposable assembly, 100; including disposable cartridge, 120, venous blood reservoir, 106, combined oxygenator/heat exchanger, 112, and arterial blood filter, 118, etc.) to an HLM base (console or control unit, 10; abstract; Figs. 1, 2A, 4, 8A-8E; [0051-0052]; [0058]), the connection assembly (1) comprising: a mounting bracket (see at least upper component mounting plate, 12) comprising a connection interface (at least at arterial filter mounting arm, 760) including a swiveling mast insert (first straight portion, 761) disposed within an aperture (of rotating assembly means, 763) defined through the mounting bracket (12) and configured to facilitate coupling the connection assembly (1) to at least one of the HLM base (10; Fig. 4; [0091]), wherein the mast (761) is coupled to the HLM base (10; via 12; Fig. 1); and a component connector (cartridge interface region, 20; Fig. 4) configured to facilitate removably connecting the HLM component (cardioplegia heat exchanger, 148) to the HLM base (10; Fig. 1), the component connector (20) comprising a fluid connection element (water connections, 147a, 147b) comprising at least one of a male tube connector or a female tube connector for connecting with a blood tube (at least tubing, 119a via cartridge, 120) of the HLM base (10; Figs. 1, 2a, 3a; [0064]; [0118]); wherein the HLM component (120, 148, 106, 112) includes a pump (arterial blood pump, 31) having an actuator control unit (ACU; at least rotatable control knob, 31a, pump information display, 31b, and system user interface, 50) directly connected to the pump (31; Fig. 1; [0053]), wherein the ACU is configured to control the pump (31; [0175]; [0393]; [0397]).
7. With regard to claim 13, Kollar discloses a heart lung machine (HLM; Figs. 1, 13-24; abstract; [0172]), comprising: an HLM base (console or control unit, 10); and a connection assembly (perfusion system, 1) coupled to the HLM base (10; Fig. 1), and configured to facilitate connecting a HLM component (disposable assembly, 100; including disposable cartridge, 120, venous blood reservoir, 106, combined oxygenator/heat exchanger, 112, and arterial blood filter, 118, etc.) to the HLM base (10; Figs. 1, 2A, 4, 8A-8E; [0051-0052]; [0058]), the connection assembly (1) comprising: a mounting bracket (see at least upper component mounting plate, 12) comprising a connection interface (at least at arterial filter mounting arm, 760) including a swiveling mast insert (first straight portion, 761) disposed within an aperture (of rotating assembly means, 763) defined through the mounting bracket (12) and configured to facilitate coupling the connection assembly (1) to at least one of the HLM base (10; Fig. 4; [0091]), wherein the mast (761) is coupled to the HLM base (10; via 12; Fig. 1); and a component connector (cartridge interface region, 20; Fig. 4) configured to facilitate removably connecting the HLM component (cardioplegia heat exchanger, 148) to the HLM base (10; Fig. 1), the component connector (20) comprising a fluid connection element (water connections, 147a, 147b) comprising at least one of a male tube connector or a female tube connector for connecting with a blood tube (at least tubing, 119 via cartridge, 120) of the HLM base (10; Figs. 1, 2a, 3a; [0064]; [0118]); wherein the HLM component (120, 148, 106, 112) includes a pump (arterial blood pump, 31) having an actuator control unit (ACU; at least rotatable control knob, 31a, pump information display, 31b, and system user interface, 50) directly connected to the pump (31; Fig. 1; [0053]), wherein the ACU is configured to control the pump (31; [0175]; [0393]; [0397]).
8. With regard to claims 4 and 15, Kollar discloses that the component connector (20) further comprises an engagement mechanism (cartridge mounting assembly, 21 and portions of 12 engaging with 763, 46, 195, 196; Fig. 4; [0061]; [0096-0098]).
9. With regard to claims 5 and 16, Kollar discloses a component support (at least 760; Fig. 4), the component support comprising: a component mount (second flexible curved portion, 762) configured to be coupled to the HLM component (118; [0090]; Fig. 1); and a support arm (761) coupled, at a first end, to the component mount (762), and extending away from the component mount (762), wherein a second end of the support arm (761) is configured to be releasably engaged by the engagement mechanism (portion of 12 engaged with 763) of the component connector (20; Fig. 4; via 763; [0090-0092]; [0226]).
10. With regard to claim 9, Kollar discloses an additional component connector (at least mounting bracket, 500) configured to facilitate removably connecting an additional HLM component (oxygenator/heat exchanger 112) to the HLM base (10; Fig. 8A; [0079-0082]).
11. With regard to claims 10 and 19, Kollar discloses that the connection assembly (1) is configured to facilitate connecting a plurality of HLM components (Fig. 1; 106, 120, 112, 118, 32-36), the plurality of HLM components comprising at least one of an additional pump (32-36), a reservoir (106; [0076-0077]), an oxygenator (112), and a sensor hub (such as sensors, 40, 42 and 44 of 20; [0135]).
12. With regard to claims 11 and 20, Kollar discloses that the plurality of HLM components (Fig. 1; 106, 120, 112, 118, 32-36) comprising a sensor hub (such as sensors, 40, 42 and 44 of 20; [0135]), the sensor hub comprising a plurality of hub connection elements (valves 401, 402, 403, 405, 406; 147a, 147b; Fig. 4), the plurality of hub connection elements comprising fluid connection elements (147a, 147b and valves 401-406) and/or data connection elements (via 10; [0175-0176]).
13. With regard to claims 12 and 21, Kollar discloses that the plurality of hub connection elements (147a, 147b and valves 401-406) comprising at least one of a temperature sensor interface (81, 88; [0096]; [0103]; [0117]), a pressure sensor interface (89; [0096]; [0109]), a level sensor interface (320, 322; [003]), and a bubble sensor interface (126; [0060]).
14. With regard to claims 23 and 24, Kollar discloses that the fluid connection element (at least 147a, 147b; Fig. 4) is configured to connect the blood tube (at least 119a) of the HLM with at least one of an input or an output of a blood pump (31) or a blood reservoir (106 or 120) of the HLM (Fig. 1; [0056]).
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.
15. Claims 7 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kollar.
16. With regard to claims 7 and 18, While Kollar discloses that the component support (760) comprises one or more support connection element (such as 762; Fig. 4), and the HLM base (10) includes fluid connection elements (147a, 147b, 195, 196, 46; [0060]; [0064]), data connection elements, and/or energy connection elements (for power up; [0328]), Kollar fails to explicitly disclose that the one or more support connection elements comprises fluid connection elements, data connection elements, and/or energy connection elements.
Nonetheless, 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 connection element disclosed by Kollar to fluid connection elements, data connection elements, and/or energy connection elements, similar to the connection elements of the HLM base disclosed by Kollar, in order to readily provide communication, whether it be fluid, data or energy, between the HLM base and the HLM component with a reasonable expectation of success, as suggested by Kollar in paragraph [0064].
16. Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Kollar in view of Lindsay (WO 00/47266 A1; previously presented).
17. With regard to claim 2, While Kollar discloses that the GLM base (10) includes a mast holder for hanging multiple solution bags (Fig. 1), Kollar is silent in regard to the connection interface further comprises a quick-connect mast holder.
However, within the same field of endeavor of HLM assemblies, Lindsay discloses a connection assembly (various mounting and interfacing structures between stand assembly/mast, 90 and heart lung machine, 91; Figs. 2A, 4) that the connection interface (at clamp, 96) further comprises a quick-connect mast holder (such as clamps, 96; Fig. 2A, 4; page 8, lines 15-21; page 19, line 11-19).
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 interface disclosed by Kollar to utilize a quick-connect mast holder, similar to that disclosed by Lindsay, in order to allow for simple vertical and rotational positioning and/or repositioning of mounting brackets for HLM components to be fixed at selected/optimal positions during the procedure, as suggested by Lindsay in on page 19, lines 15-21.
18. Claims 6, 8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kollar in view of Brennan et al. (US PGPUB 2015/0144514).
19. With regard to claims 6, 8 and 17, Kollar is 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 Kollar 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].
Conclusion
20. 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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