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 .
Election/Restrictions
Applicant’s election without traverse of Invention I (claims 1-9) in the reply filed on 04/20/2026 is acknowledged.
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/20/2026.
Information Disclosure Statement
The information disclosure statement(s) (IDS) were submitted on:
01/16/2024
04/05/2024
05/06/2024
Accordingly, the information disclosure statement(s) are being considered by the examiner.
The information disclosure statement filed 01/16/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed:
Foreign Patent Documents, Citation #1: IB-1988005261
The IDS has been placed in the application file, but the information referred to therein has not been considered. Instead, the following documentation that was filed was considered in its place:
WO-8805261
Specification
The disclosure is objected to because of the following informalities:
Regarding the specification, at least paragraphs [0045], [0048], [0050], [0055], [0062]-[0063], [0070], [0072]-[0073], [0080], [00108], [00113], [00125], and [00127] recite information given by generative artificial intelligence. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Regarding the specification, at least paragraphs [00114]-[00116] contain the term “doner”; the term “donor” should be used instead.
Regarding the specification, at least paragraph [00114] contains the term “thru”; the term “through” should be used instead.
Regarding the specification, at paragraph [00291], the term “Wi-Fi” is used. The use of the term “Wi-Fi”, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Objections
Claims 1 and 6 are objected to because of the following informalities:
Regarding claim 1, line 8, the term “supplies perfusate” should be “supplies the perfusate”.
Regarding claim 6, line 2, the term “in automated operation mode” should be “in the automated operation mode”.
Regarding claim 6, lines 2-3, the term “in manual operation mode” should be “in the manual operation mode”.
Appropriate correction is required.
Claim Interpretation
Regarding claim 8, the terms “Partial Working Mode Perfusion” and “Left Atrial Perfusion”, according the instant specification, these terms are interchangeable (instant specification, paragraph [00116]).
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 8 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.
Claim 8 is rejected on the basis that it contains an improper Markush grouping of alternatives. In essence, the term “comprising” is used when “consisting of” should replace the term, resulting in a proper Markush group. Applicant is notified that the terms “and/or” or “and combinations thereof” could be amended into claim 8 based on the instant specification at paragraph [00113].
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.
Claims 1-2, 4-7, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Hassanein-4357 (US 20060154357) (previously cited in the International Search Report filed 05/06/2024) in view of Freed (US 20150017710) (newly cited) and Brassil (US 20220408720) (newly cited). Regarding claim 1, Hassanein-4357 discloses a system for perfusion of an organ (paragraph [0009]), the system comprising:
an organ chamber (paragraph [0011] “organ chamber assembly”) configured to house an organ (paragraph [0011] “heart”);
a fluid circuit (Fig. 1 and paragraph [0101]) comprising:
tubing that couples to the organ within the organ chamber and carries a perfusate to and from the organ (Figs. 3-4 and paragraph [0090] and paragraph [0225] “perfusate lines”);
a pump coupled to the tubing (Figs. 3-4 and paragraph [0011]), the pump configured to drive the perfusate through the fluid circuit (paragraph [0011]);
a reservoir (paragraph [0011]) that supplies perfusate to the tubing for use in the fluid circuit;
an oxygenator (paragraph [0011]) coupled to the tubing and configured to exchange oxygen gas (paragraph [0013]) with waste gas (paragraph [0097] “carbon dioxide”, inherent to the heart that a waste gas can be carbon dioxide) in the perfusate;
a hemofilter (paragraph [0198]) coupled to the tubing and configured to remove an ultrafiltrate comprising metabolic waste (paragraph [0198] “debris, blood particles, emboli, and air bubbles”) from the perfusate; and
a controller (paragraph [0097] “controller 150”) coupled to the fluid circuit, the controller configured to manage a plurality of perfusion parameters of the fluid circuit to perfuse the organ (paragraphs [0097], [0115], [0138] “gas flow into the oxygenator”, “temperatures”, and “the pumping” subsystems).
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Hassanein-4357, Fig. 1
Hassanein-4357 does not disclose:
a replaceable reservoir
a filtrate replacement fluid coupled to the fluid circuit and configured to supply filtrate replacement fluid to the perfusate.
Regarding feature 1, Freed discloses a replaceable reservoir (paragraph [0039]).
In the analogous art of apparatuses for heart transplantation, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of Hassanein-4357 with the replaceable reservoir of Freed in order to replace the reservoir to sterilize the reservoir of the apparatus for multiple uses.
Regarding feature 2, Brassil discloses a filtrate replacement fluid coupled to the fluid circuit and configured to supply filtrate replacement fluid to the perfusate (paragraph [0125] “reservoir bottle … stores and supplies dialysate”).
In the analogous art of apparatuses for organ isolation, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of Hassanein-4357 with the filtrate replacement fluid of Brassil in order to filter wastes from perfusate but add replacement fluid for the perfusate fluid filtered out with the wastes so that the total amount of fluid in the system remains constant over time allowing for predictable and steadier operating states.
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Brassil, Fig. 1
Regarding claim 2, Hassanein-4357 discloses wherein the reservoir (paragraph [0011]) is configured to supply clean perfusate (paragraph [0011]) without interrupting perfusion of the organ (paragraph [0029], system is intended to be operated without interruption).
Regarding the term “replaceable reservoir”, see Freed’s disclosure above to parent claim 1.
Regarding claim 4, Hassanein-4357 does not disclose wherein the replaceable reservoir comprises:
a first supply reservoir configured to be coupled to the fluid circuit;
a second supply reservoir configured to be coupled to the fluid circuit; and
a bulk perfusate diversion system configured to exchange perfusate in the first supply reservoir with perfusate in the second supply reservoir for a bulk removal of metabolic waste in the perfusate.
Regarding the term “replaceable reservoir”, see Freed’s disclosure above to parent claim 1.
Brassil discloses a first supply reservoir configured to be coupled to the fluid circuit (Fig. 1, element 1 “cassette” contains element 3 “perfusate”);
a second supply reservoir configured to be coupled to the fluid circuit (Fig. 1, element 40 “dialysis reservoir”); and
a bulk perfusate diversion system (Fig. 1, element 39 “dialysis filter”; paragraph [0048]) configured to exchange perfusate in the first supply reservoir (Fig. 1, element 1 “cassette” contains element 3 “perfusate”) with perfusate in the second supply reservoir (Fig. 1, element 40 “dialysis reservoir”) for a bulk removal of metabolic waste in the perfusate (paragraph [0048]).
In the analogous art of apparatuses for organ isolation, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of Hassanein-4357 with the first supply reservoir, second supply reservoir, and bulk perfusate diversion system of Brassil in order to supply perfusate and replacement fluid for the perfusate fluid in order to filter out wastes so that the organ remains viable over the time that the perfusate is recirculated in the fluid circuit.
Regarding claim 5, Hassanein-4357 discloses further comprising:
a user interface configured to display information to an operator and accept input data from the operator for perfusion parameters for manual operation mode of at least one control loop of a plurality of control loops of the system (paragraph [0151] “operator interface”); and
wherein the controller (paragraph [0097] “controller 150”) is configured to transition the at least one control loop from manual operation mode to automated operation mode in response to user input from the operator (paragraph [0154] “manually impose, or adjust … a subsystem” and/or “automatically program the pumping subsystem”).
Regarding claim 6, Hassanein-4357 discloses wherein the controller (paragraph [0097] “controller 150”) is configured to operate the at least one control loop in automated operation mode (paragraph [0154] “manually impose, or adjust … a subsystem” and/or “automatically program the pumping subsystem”) while another one of the plurality of control loops operates in manual operation mode (paragraph [0159] “provide manual control over the operation of the system 100. For example, the knob 626 may be used to provide instructions to the controller 150 to increase perfusion fluid flow rates, gas flow rates, etc.”).
Regarding claim 7, Hassanein-4357 discloses wherein the controller modulates the plurality of perfusion parameters of the fluid circuit to perfuse the organ based on a perfusion protocol (paragraphs [0143], [0145], [0151], and [0154]).
Regarding claim 9, Hassanein-4357 discloses wherein the controller modulates a rate of the perfusate based on a measured parameter of at least one of the organ and the fluid circuit (paragraph [0017]).
Hassanein-4357 does not disclose wherein the controller modulates a rate of at least one of filtrate replacement fluid supplied to the perfusate and ultrafiltrate removal based on a measured parameter of at least one of the organ and the fluid circuit.
Brassil discloses wherein the controller (paragraphs [0098] and [0103], Fig. 1, element 15 “CPU”) modulates a rate of at least one of filtrate replacement fluid supplied to the perfusate and ultrafiltrate removal based on a measured parameter of at least one of the organ and the fluid circuit (paragraph [0112], Fig. 1, element 26 “pressure sensor”; paragraph [0118], Fig. 1, element 36 “flow sensor”; paragraphs [0123]-[0124], Fig. 1, element 42.1, “Dialysis pressure sensor”).
In the analogous art of apparatuses for organ isolation, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of Hassanein-4357 with the controller modulating the flow of the filtrate replacement fluid and ultrafiltration removal based on measured parameters of Brassil in order to manage perfusion pressure, flow, and pulsatility (Brassil, paragraph [0098]), and so that lactate, one of the waste products, can be removed from the perfusate for less feedback inhibition of glycolysis in the organ, resulting in viability improvements (Brassil, paragraph [0175]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Hassanein-4357 (US 20060154357) (previously cited in the International Search Report filed 05/06/2024) in view of Freed (US 20150017710) (newly cited) and Brassil (US 20220408720) (newly cited) as applied in claim 1, further in view of Hassanein-5011 (WO 9915011) (newly cited).
Regarding claim 3, Hassanein-4357 discloses the reservoir (paragraph [0011]).
Hassanein-4357 does not disclose wherein the replaceable reservoir comprises a first filter, a second filter, and a diverter that when activated redirects at least a portion of the perfusate from the first filter to the second filter.
Hassanein-5011 discloses wherein the reservoir comprises a first filter and a second filter (Fig. 5, elements 214 are a pair of filters in parallel and pg. 27, first full paragraph).
Regarding the term “diverter”, Hassanein-5011 discloses a flow control means (pg. 6, letter “h”) and a Y-connector (pg. 29, first half paragraph) within their invention.
In the analogous art of devices for maintaining an organ, it would have been obvious to one skilled in the art before the effective filing date to modify modified Hassanein-4357 with the pair of filters of Hassanein-5011, the flow control means, and the Y-connector of Hassanein-5011 in order to branch the flow of perfusate and control the total flow between the branches; the pair of filters receives flow of perfusate from these branches in parallel.
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Hassanein-011, Fig. 5
Regarding the term “replaceable reservoir”, see Freed’s disclosure above to parent claim 1.
Regarding the phrase “that when activated redirects at least a portion of the perfusate from the first filter to the second filter”, this would be expected based on the placement of a flow control means within a Y – connector. Additionally, the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of modified Hassanein-4357 would be fully capable of operating in this manner given the Y-connector and a flow control means.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Hassanein-4357 (US 20060154357) (previously cited in the International Search Report filed 05/06/2024) in view of Freed (US 20150017710) (newly cited) and Brassil (US 20220408720) (newly cited) as applied to claim 7; or alternatively, under 35 U.S.C. 103 as obvious over Hassanein-4357 (US 20060154357) (previously cited in the International Search Report filed 05/06/2024) in view of Freed (US 20150017710) (newly cited) and Brassil (US 20220408720) (newly cited) as applied to claim 7, further in view of Sciortino (US 20230217916) (newly cited).
Regarding claim 8, Hassanein-4357 discloses wherein the organ is a heart (paragraph [0009]), and the perfusion mode is a working mode perfusion (normal flow mode in paragraph [0010]) and a “Langendorff” perfusion (retrograde aortic flow mode in paragraph [0010]).
Hassanein-4357 does not disclose wherein the perfusion protocol includes a perfusion mode selected from the group comprising, “Partial Working Mode Perfusion” and “Left Atrial Perfusion”.
Regarding the terms “Partial Working Mode Perfusion” and “Left Atrial Perfusion”, according the instant specification, these terms are interchangeable (instant specification, paragraph [00116]).
Regarding the limitations above, if the limitation is deemed to be phrased in the alternative, at least one of the limitations is rejected above, and no further rejections are required at this time.
However, if this limitation is deemed not to have been met, and the claim language is deemed to use open-ended “comprising” language, Sciortino discloses “Left Heart Working Mode” which is same as “Left Atrial Perfusion” or “Partial Working Mode Perfusion” (paragraphs [0009], [0014], and [0055]) as well as the other modes of perfusion (paragraph [0014] “Langendorff Perfusion Mode” and “Whole Heart Working Mode”).
In the analogous art of ex-vivo heart perfusion systems, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of Hassanein-4357 with the protocols of Sciortino in order to perfuse the heart in different methods for a variety of reasons, including: resuscitation under Langendorff perfusion mode (Sciortino, paragraphs [0053] and [0055]), testing for ventricular contractility for myocardial viability (Sciortino, paragraph [0055]), working mode for simulating full physiological circulation (Sciortino, paragraph [0052]).
Additional Prior Art References
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure.
Minten (US 5716378) (newly cited) – This invention is a heart preservation and transportation apparatus.
Freed (US 20170339945) (newly cited) – This invention is an apparatus for organ perfusion that contains different modes of heart perfusion.
Kravitz (US 20200187490) (previously cited) – This invention has serial filtration among two filters for organ perfusion devices.
Bier (US 3843455) (newly cited) – This invention is an organ perfusion device with an organ box that comprises a filter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN G ESPERON whose telephone number is 571-272-9807. The examiner can normally be reached 9 am - 6 pm Monday through Thursday, and 9 am - 6 pm every other Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.G.E./Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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