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 Group I (claims 1-11, 13, and 18-23) in the reply filed on 11/04/2025 is acknowledged.
Claims 29 and 33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.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 11/04/2025.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement(s) (IDS) were submitted on:
08/11/2022
11/01/2023
Accordingly, the information disclosure statement(s) are being considered by the examiner.
Claim Objections
Claims 1-2, 5-8, and 13 are objected to because of the following informalities:
Regarding claim 1, in lines 9, 12, and 14, the term “persufflation fluid” should be “the persufflation fluid”.
Regarding claim 2, in lines 3-4, the phrase “to a said oxygen supply system” should be “to the oxygen supply system”.
Regarding claim 2, in lines 4, the phrase “of a said storage apparatus” should be “of the storage apparatus”.
Regarding claims 5-6, the term “organ preservation liquid” should be “the organ preservation liquid”.
Regarding claim 6, in line 3, the term “gaseous mixture” should be “the gaseous mixture”.
Regarding claim 7, in line 2, the term “persufflation fluid” should be “the persufflation fluid”.
Regarding claim 8, delete the space after the phrase “claim 1”.
Regarding claim 8, in line 3, the term “persufflation fluid” should be “the persufflation fluid”.
Regarding claim 13, in lines 2-3, the term “persufflation fluid” should be “the persufflation fluid”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a bubble break element arranged within the internal passageway to reduce bubble size of the persufflation fluid flowing through the internal passageway from the inlet port to the outlet port” in claim 9
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim 9 is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. A review of the specification as filed shows that the following appears to be the corresponding structures, materials, or acts described in the specification as filed for the following 35 U.S.C. § 112(f) limitations:
A bubble break element may comprise an element which is sized and/or shaped so that bubbles in fluid (e.g. gas) flowing past the element will be reduced in size. This may comprise use of elements which protrude into the internal passageway, e.g. which are small and/or angular enough in one region of the element to reduce bubble size.
pg. 3 of the instant specification
The bubble break up elements can be pegs or beads or plates or hemispherical or tapered projections or other such elements that operate to create a longer pathway in the internal passageway and/or provide shattering surfaces and/or define interspatial gaps that preclude transfer of large bubbles.
pg. 18 of the instant specification
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 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.
Regarding claim 23, the term “a second venting port” is recited, but due to the construction of the claim dependencies, there is no “first venting port” recited in the parent claim 22 or in the independent claim 1 (the respective parent claim of claim 22). Instead, “a first venting port” is first recited in claim 19, but this claim (claim 23) has a different dependency from independent 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5 and 8 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Tempelman (US 20120178150) (previously cited).
Regarding claim 1, Tempelman discloses a container unit (paragraph [0097], Fig. 4, element 200 “container body”) for storing an organ or body tissue (paragraphs [0012]-[0013] and [0049] “tissue” or “organ”), wherein the container unit is configured as an insert (paragraph [0103]) for a storage apparatus (paragraph [0103], Fig. 4, element 600 “system”) for preserving a said organ or body tissue (abstract), wherein the container unit comprises:
a container body (paragraph [0097], Fig. 4, element 200 “container body”) defining a storage region (paragraph [0033] “storage container” or paragraph [0108] “organ container”) for storing an organ or body tissue (paragraphs [0012]-[0013] and [0049] “tissue” or “organ”);
an inlet port for connection to a fluid supply system of a said storage apparatus to receive persufflation fluid from the storage apparatus (paragraphs [0033] and [0097] “a fluid conduit fluidly coupled to the gas generator”, the fluid conduit has at least a port on both sides, at least one of which is an inlet);
an outlet port for connection to a said organ or body tissue stored in the container body to enable persufflation fluid to be delivered to said organ or body tissue (paragraphs [0030], [0033], and [0097] “the system may further comprise a quantity of a liquid, wherein the preserving gas is dissolved in the liquid to form a gas/liquid solution, the gas/liquid solution being delivered to the tissue by the fluid conduit”, the fluid conduit has at least a port on both sides, at least one of which is an outlet; and, “a fluid conduit fluidly coupled to the gas generator and insertable into tissue”); and
a fluid processing device (paragraphs [0030], [0033], and [0097] “fluid conduit”) comprising an internal passageway (paragraphs [0030], [0033], and [0097] “fluid conduit fluidly coupled to the gas generator and insertable into tissue”) connecting the inlet port to the outlet port to enable persufflation fluid to flow from the inlet port to the outlet port (paragraphs [0030], [0033], and [0097] both sides of the fluid conduit have ports), wherein the fluid processing device is configured to process persufflation fluid (paragraph [0050] for definition of persufflation according to Tempelman; paragraph [0097] for one or more fluid conduits in the persufflator system; Fig. 1, elements 550 “fluid conduits” and 100 “persufflator system”) flowing through the internal passageway (paragraphs [0030], [0033], and [0097] “fluid conduit fluidly coupled to the gas generator and insertable into tissue”) from the inlet port to the outlet port (paragraphs [0030], [0033], and [0097] “fluid conduit” has at least a port on both sides, at least one of which is an inlet and at least one other is an outlet).
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Tempelman, Fig. 1
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Regarding claim 2, Tempelman discloses wherein the fluid supply system of the storage apparatus comprises an oxygen supply system (paragraphs [0033] and [0097] “a fluid conduit fluidly coupled to the gas generator” and paragraphs [0014]-[0016] “oxygen”) and the persufflation fluid comprises a gaseous mixture (paragraph [0067]), and wherein the inlet port is for connection (paragraphs [0033] and [0097] “a fluid conduit fluidly coupled to the gas generator”, the fluid conduit has at least a port on both sides, at least one of which is an inlet) to a said oxygen supply system (paragraphs [0033] and [0097] “a fluid conduit fluidly coupled to the gas generator” and paragraphs [0014]-[0016] “oxygen”) of a said storage apparatus (paragraph [0103], Fig. 4, element 600 “system”) to receive a gaseous mixture therefrom (paragraph [0067]).
Regarding claim 3, Tempelman discloses wherein the fluid processing device comprises a gas humidifier (paragraph [0089] inherent to “producing gas that is humidified”) and heat exchanger (paragraph [0086] “oxygen cooler”).
Regarding claim 4, Tempelman discloses wherein the storage region (paragraph [0033] “storage container” or paragraph [0108] “organ container”) is arranged to receive an organ preservation liquid (paragraph [0108]) in which the organ or body tissue is to be stored (paragraphs [0033] and [0049] “for storing the biological matter comprising tissue” and paragraph [0108] “organ container”).
Regarding claim 5, Tempelman discloses wherein the internal passageway (paragraphs [0030], [0033], and [0097] “fluid conduit fluidly coupled to the gas generator and insertable into tissue”) comprises an organ preservation liquid (paragraph [0030] “gas/liquid solution”) inlet (paragraphs [0033] and [0097] “a fluid conduit fluidly coupled to the gas generator”, the fluid conduit has at least a port on both sides, at least one of which is an inlet) arranged to enable organ preservation liquid (paragraph [0030] “gas/liquid solution”) in the storage region (paragraph [0033] “storage container” or paragraph [0108] “organ container”) to flow into the internal passageway (paragraphs [0030], [0033], and [0097] “fluid conduit fluidly coupled to the gas generator and insertable into tissue”).
Regarding claim 8, Tempelman discloses wherein the fluid processing device (paragraphs [0030], [0033], and [0097] “fluid conduit”) comprises at least one obstruction (paragraph [0112] “filters”) arranged within the internal passageway (paragraphs [0030], [0033], and [0097] “fluid conduit fluidly coupled to the gas generator and insertable into tissue”) to disrupt the flow of persufflation fluid (paragraph [0050] for definition of persufflation according to Tempelman; paragraph [0097] for one or more fluid conduits in the persufflator system; Fig. 1, elements 550 “fluid conduits” and 100 “persufflator system”) flowing through the internal passageway (paragraphs [0030], [0033], and [0097] “fluid conduit fluidly coupled to the gas generator and insertable into tissue”) from the inlet port (paragraphs [0033] and [0097] “a fluid conduit fluidly coupled to the gas generator”, the fluid conduit has at least a port on both sides, at least one of which is an inlet) to the outlet port (paragraphs [0030], [0033], and [0097] “the system may further comprise a quantity of a liquid, wherein the preserving gas is dissolved in the liquid to form a gas/liquid solution, the gas/liquid solution being delivered to the tissue by the fluid conduit”, the fluid conduit has at least a port on both sides, at least one of which is an outlet; and, “a fluid conduit fluidly coupled to the gas generator and insertable into tissue”).
Claim Rejections - 35 USC § 102 | 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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 10 is rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as anticipated by Tempelman (US 20120178150) (previously cited) as applied to claim 1, or, in the alternative, under 35 U.S.C. 103 as obvious over Tempelman (US 20120178150) (previously cited) as applied to claim 1.
Regarding claim 10, Tempelman discloses wherein the internal passageway is arranged to define at least one bend through which the persufflation fluid will flow when flowing from the inlet port to the outlet port (paragraph [0116] and Fig. 6, element 2103 “tubing” has a bend in the figure).
Alternatively, the claim limitation is obvious, as the configuration of the claimed shape is a matter of choice, absent persuasive evidence that the particular configuration is significant. MPEP § 2144.04(IV)(B). It would have been obvious to one skilled in the art before the effective filing date to modify the shape of the internal passageway of Tempelman to have at least one bend in order to coil the internal passageway to make the length of the passageway more compact spatially for storage during transport, but also allow for extended lengths of tubing so that the internal components of the apparatus can be assembled and/or taken apart for operative and sterilizing steps.
Claims 19-20 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as anticipated by Tempelman (US 20120178150) (previously cited) as applied to claim 1, or, in the alternative, under 35 U.S.C. 103 as obvious over Tempelman (US 20120178150) (previously cited) as applied to claim 1, in view of De Muylder (US 20210076668) (newly disclosed).
Regarding claim 19, Tempelman discloses wherein the container unit comprises a first venting port operable to enable pressure within the container unit and/or storage region to be reduced (paragraph [0095]).
Regarding the limitation “operable to enable pressure within the container unit and/or storage region to be reduced”, 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 Tempelman would be fully capable of operating in this manner given its reservoir vent port.
If it is deemed that Tempelman does not disclose a venting port, De Muylder discloses wherein the container unit comprises a first venting port operable to enable pressure within the container unit and/or storage region to be reduced (paragraph [0061]).
In the analogous art of organ perfusion systems, it would have been obvious to one skilled in the art before the effective filing date to modify Tempelman’s container unit with the venting port of De Muylder in order to allow for gas transfer in order to maintain pressure equilibrium (De Muylder, paragraph [0061]).
Regarding claim 20, Tempelman discloses wherein the container unit comprises an outer lid for sealing the container unit (paragraph [0103]).
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.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Tempelman (US 20120178150) (previously cited) as applied to claim 5.
Regarding claim 6, Tempelman discloses wherein at least one surface of the internal passageway (paragraphs [0030], [0033], and [0097] “fluid conduit fluidly coupled to the gas generator and insertable into tissue”), heat exchange (paragraph [0086] “oxygen cooler”), organ preservation liquid (paragraph [0030] “gas/liquid solution”) in the storage region (paragraph [0033] “storage container” or paragraph [0108] “organ container”), and gaseous mixture (paragraph [0067]) in the internal passageway (paragraphs [0030], [0033], and [0097] “fluid conduit fluidly coupled to the gas generator and insertable into tissue”).
However, Templeman does not disclose the limitation: the internal passageway is arranged to provide heat exchange between organ preservation liquid.
Nevertheless, regarding the limitation “wherein at least one surface of the internal passageway is arranged to provide heat exchange between organ preservation liquid in the storage region and gaseous mixture in the internal passageway”, rearrangement of parts would have been obvious to one of ordinary skill in the art as an obvious matter of design choice and would not have modified the operation of the device. MPEP § 2144.04(VI)(C). Additionally, it would have been obvious to one skilled in the art before the effective filing date to modify the internal passageway of Tempelman with the provision of heat exchange of Tempelman in order to keep the temperature between the organ preservation liquid in the storage region and gaseous mixture in the internal passageway at a suitable level to either cool the organ for transport (Tempelman, see example in paragraph [0076]) or heat the organ (Tempelman, paragraph [0099]), such as for transplant.
Regarding claim 7, Tempelman discloses wherein the fluid processing device (paragraphs [0030], [0033], and [0097] “fluid conduit”) being configured to process persufflation fluid (paragraph [0050] for definition of persufflation according to Tempelman; paragraph [0097] for one or more fluid conduits in the persufflator system; Fig. 1, elements 550 “fluid conduits” and 100 “persufflator system”) flowing through the internal passageway (paragraphs [0030], [0033], and [0097] “fluid conduit fluidly coupled to the gas generator and insertable into tissue”) from the inlet port (paragraphs [0033] and [0097] “a fluid conduit fluidly coupled to the gas generator”, the fluid conduit has at least a port on both sides, at least one of which is an inlet) to the outlet port (paragraphs [0030], [0033], and [0097] “the system may further comprise a quantity of a liquid, wherein the preserving gas is dissolved in the liquid to form a gas/liquid solution, the gas/liquid solution being delivered to the tissue by the fluid conduit”, the fluid conduit has at least a port on both sides, at least one of which is an outlet; and, “a fluid conduit fluidly coupled to the gas generator and insertable into tissue”) comprises the gas humidifier (paragraph [0089] inherent to “producing gas that is humidified”) and heat exchanger (paragraph [0086] “oxygen cooler”) being configured to provide humidifying and cooling of the gaseous mixture (paragraph [0067]) prior to supplying (Fig. 2, element 100 contains element 121 “oxygen cooler” and can omit element 125 “oxygen drier or desiccant” according to paragraph [0089] to produce a gas that is humidified – this element 100 in Figs. 1-2 leads to Fig. 1, element 550 “fluid conduit”, which leads to Fig. 1, element 200 “container”) said cooled and humidified gaseous mixture to said organ or body tissue (paragraphs [0012]-[0013] and [0049] “tissue” or “organ”).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Tempelman (US 20120178150) (previously cited) as applied to claim 8, in view of Baker (US 20060121439) (newly cited).
Regarding claim 9, Tempelman discloses the internal passageway (paragraphs [0030], [0033], and [0097] “fluid conduit fluidly coupled to the gas generator and insertable into tissue”) and the persufflation fluid (paragraph [0050] for definition of persufflation according to Tempelman; paragraph [0097] for one or more fluid conduits in the persufflator system; Fig. 1, elements 550 “fluid conduits” and 100 “persufflator system”) flowing through the internal passageway from the inlet port to the outlet port (paragraphs [0030], [0033], and [0097] both sides of the fluid conduit have ports).
Tempelman does not disclose wherein the at least one obstruction comprises at least one (i) a bubble break element arranged within the internal passageway to reduce a bubble size of the persufflation fluid and (ii) a baffle.
Baker discloses wherein the at least one obstruction comprises at least one (i) a bubble break element arranged within the internal passageway to reduce a bubble size of the persufflation fluid (paragraphs [0024] and [0067] “gas bubbler”).
In the analogous art of organ preservation and transportation apparatuses, it would have been obvious to one skilled in the art before the effective filing date to modify modified Tempelman with the obstruction of Baker in order to produce small gas bubbles to perfuse the liquid medium (Baker, paragraph [0067]).
Regarding the limitation, “and (ii) a baffle”, this limitation is listed in the alternative and is not required to be rejected at this time.
Claim 11 are rejected under 35 U.S.C. 103 as being unpatentable over Tempelman (US 20120178150) (previously cited) as applied to claim 1.
Regarding claim 11, Tempelman discloses the internal passageway (paragraphs [0030], [0033], and [0097] “fluid conduit fluidly coupled to the gas generator and insertable into tissue”).
Tempelman does not disclose wherein the internal passageway has a serpentine shape.
However, the claim limitation is obvious, as the configuration of the claimed shape is a matter of choice, absent persuasive evidence that the particular configuration is significant. MPEP § 2144.04(IV)(B). It would have been obvious to one skilled in the art before the effective filing date to modify the shape of the internal passageway of Tempelman to have a serpentine shape in order to coil the internal passageway to make the length of the passageway more compact spatially for storage during transport, but also allow for extended lengths of tubing so that the internal components of the apparatus can be assembled and/or taken apart for operative and sterilizing steps.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Tempelman (US 20120178150) (previously cited) as applied to claim 5, in view of Woodard (US 20160113269) (newly cited).
Regarding claim 13, Tempelman discloses wherein the fluid processing device further comprises a valve arranged to inhibit flow of persufflation fluid from the internal passageway through the preservation liquid inlet into the storage region (paragraph [0097] “valves”).
Tempelman does not disclose: a one-way valve.
However, regarding the limitation “a one-way valve”, it would have been obvious to one skilled in the art before the effective filing date to modify the valve of Tempelman to be a one-way valve so that no fluid flow would be reversed back into the fluid processing device from the storage region.
Nevertheless, Woodard discloses a one-way valve (paragraph [0059]).
In the analogous art of organ perfusion systems and devices, it would have been obvious to one skilled in the art before the effective filing date to modify the valve of Tempelman to be a one-way valve of Woodard so that no fluid flow would be reversed back into the fluid processing device from the storage region (Woodard, paragraph [0059]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Tempelman (US 20120178150) (previously cited) as applied to claim 1.
Regarding claim 18, Tempelman discloses wherein at least one surface of the fluid processing device (paragraphs [0030], [0033], and [0097] “fluid conduit”) is connected to (paragraph [0116] and Fig. 6) the storage region (paragraph [0033] “storage container” or paragraph [0108] “organ container”).
Tempelman does not disclose: the fluid processing device is integral with the storage region.
However, regarding the limitation “at least one surface of the fluid processing device is integral with the storage region”, integration of parts would have been obvious to one of ordinary skill in the art as a matter of obvious engineering choice. MPEP § 2144.04(V)(B). It would have been obvious to one skilled in the art before the effective filing date to modify Tempelman’s connections to be integral in order to facilitate ease of use of the invention so that the user does not need to assemble the connections.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Tempelman (US 20120178150) (previously cited) as applied to claim 20, in view of De Muylder (US 20210076668) (newly disclosed).
Regarding claim 21, Tempelman discloses the outer lid (paragraph [0103]) and the first venting port (paragraph [0095]).
If it is deemed that Tempelman does not disclose wherein the outer lid comprises the first venting port, De Muylder discloses wherein the outer lid comprises the first venting port (paragraph [0061]).
In the analogous art of organ perfusion systems, it would have been obvious to one skilled in the art before the effective filing date to modify Tempelman’s container unit with the venting port of De Muylder in order to allow for gas transfer in order to maintain pressure equilibrium (De Muylder, paragraph [0061]).
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Tempelman (US 20120178150) (previously cited) as applied to claim 1, in view of De Muylder (US 20210076668) (newly disclosed).
Regarding claim 22, Tempelman discloses wherein the container unit comprises a lid (paragraph [0103]) and the organ or body tissue (paragraphs [0012]-[0013] and [0049] “tissue” or “organ”) within the storage region (paragraphs [0042] and [0103], Fig. 4, element 600 “system”).
Tempelman does not disclose wherein the container unit comprises an inner lid arranged to seal the organ or body tissue within the storage region.
De Muylder discloses wherein the container unit comprises an inner lid arranged to seal the organ or body tissue within the storage region (paragraph [0061]).
In the analogous art of organ containers with an oxygenation option, it would have been obvious to one skilled in the art before the effective filing date to modify the container unit of Tempelman with the inner lid of De Muylder in order to create a substantially fluid-tight seal with the container and to prevent contamination (De Muylder, paragraph [0061]).
Regarding claim 23, Tempelman discloses a lid (paragraph [0103]), a venting port (paragraph [0095]), and the storage region (paragraph [0103], Fig. 4, element 600 “system”).
Tempelman does not disclose wherein the inner lid comprises a second venting port operable to enable pressure within the storage region to be reduced.
De Muylder discloses wherein the inner lid comprises a second venting port operable to enable pressure within the storage region to be reduced (paragraph [0061]).
In the analogous art of organ perfusion systems, it would have been obvious to one skilled in the art before the effective filing date to modify Tempelman’s container unit with the venting port of De Muylder in order to allow for gas transfer in order to maintain pressure equilibrium (De Muylder, paragraph [0061]).
Additional Prior Art References
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure.
Tempelman (US 20100330547) (newly cited) – This invention is about perfusing an organ with an in situ generated gas.
Tempelman (GB 2498096) (as cited by the IDSs from 08/11/2022 and 11/01/2023) – This invention is a system for fluid perfusion of biological matter comprising tissue.
Kay (US 20140377849) (newly cited) – This invention is an organ perfusion system, by one of the instant application’s inventors.
Niazi (US 20110201050) (newly cited) – This invention is a Gas Scrubbed Perfusion Filter which can be applied to extracorporeal organ perfusion (see claim 22).
Conclusion
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/N.G.E./Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799