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 .
Manner of Making Amendments to Patent Applications
Regarding the preamble to the claim set, under “Listing of Claims”, the current claims recite the phrase “the”, which does not appear to have all of the proofreading markings that show that it has been amended. MPEP § 1.121(c)(2). Please see the corresponding claim objection. This entire phrase needs to be deleted.
Specification
The disclosure is objected to because of the following informalities:
Regarding the specification, at paragraph [0014], in line 6, the term “supplied” is misspelled.
Regarding the specification, at paragraphs [0017], in line 2, the term “leaving” is misspelled.
Regarding the specification, at paragraph [0034], 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 § 608.01.3
Regarding the specification, after paragraphs [0047] and [0064], there are large spaces after these paragraphs.
Regarding the specification, at some points in the specification, the font is gray; all text should be in black font.
Appropriate correction is required.
Claim Objections
The claim set is objected to because of the following informalities:
Regarding the claim set, in the beginning of the claim set, under “Listing of Claims”, the term “the” is present, but should be deleted.
Regarding claim 1, in line 3, the term “said tissue container” should be “the tissue container” to match the grammar of the claim set.
Appropriate correction is required.
Claim Interpretation
Regarding claim 1, in the preamble, the term “a tissue” will be interpreted under broadest reasonable interpretation to encompass organs (also, see the specification at paragraph [0001]).
Regarding claim 13, the term “a specific tissue” will be interpreted under broadest reasonable interpretation, and can encompass any specific tissue.
Regarding claims 14-15, the three recitations of the term “and/or” will be interpreted under broadest reasonable interpretation. At least the alternative of the limitations is applied; optionally, the combination of limitations is applied.
Regarding claim 15, the claim recites the limitation “standoff features”. This term will be interpreted under broadest reasonable interpretation, according to MPEP § 2117(II)(A) as it is similar to the example about “the fastener selected from the group consisting of a pressure sensitive adhesive and complementary release material, a complementary hook and loop structure, a snap, and a buckle”. In addition, according to the specification, two examples of standoff features appear in paragraph [0022], “standoff clamps” and “one or more standoff features … such as bent finger-like projections”.
Regarding claim 23, the claim recites “wherein the at least one sensor provides the sensor data to at least one controller, the at least one controller driving a display, the display being configured to present the sensor data”. This limitation is being interpreted as a controller-based limitation.
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:
“structures in the tissue container for management of cabling and/or tubing to support the cabling and/or tubing away from the tissue” in claim 14
“at least one mounting device configured to position the at least one sensor within a pre-selected range of the tissue” in claim 18.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claims 14 and 18 are 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:
Regarding the limitation “structures in the tissue container for management of cabling and/or tubing to support the cabling and/or tubing away from the tissue” in claim 14, the specification describes – “Part of the floor can be configured to manage the tubing or possibly cabling. Tube management can include, but is not limited to including, weld mount clamps, rail clamps, magnetic clamps, snap-in clamps, multiline clamps, connectable clamps, expansion clamps, adhesive-back clamps, lock-close strut-mount clamps, standoff clamps, low profile clamps, and loop clamps” (instant specification, paragraph [0022])
Regarding the limitation “at least one mounting device configured to position the at least one sensor within a pre-selected range of the tissue” in claim 18, the specification describes – “sensor mount 30180 (FIG. 2B) provide mounting and protective locations for sensors that can monitor the health of the tissue in the tissue container” and “Assembly 20038 (FIG. 9A) includes sensor cover 30181 (FIG. 9A), sensor mount 30180 (FIG. 9A), hood handle 30178 (FIG. 9A), and hood housing 30177 (FIG. 9A). A sensor such as camera 40059 (FIG. 9A) is mounted upon sensor mount 30180 (FIG. 9A) and protected from the environment by sensor cover 30181 (FIG. 9A) and hood housing 30177 (FIG. 9A). Other types of sensors can be mounted upon sensor mount 30180 (FIG. 9A), for example, sensors that detect characteristics of the underlying tissue” (instant specification, paragraphs [0073] and [0085])
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-3 and 5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 2-3 and 5 and the 35 U.S.C. 112(a) rejection and 112(b) rejection:
Claims 2-3 and 5 include the limitation “the support assembly”
however, the written description fails to provide adequate support for claims 2-3 and 5 under 35 U.S.C. 112(a). The limitation is too broad in all its various embodiments to be supported by the specification: e.g., a support assembly could be a mechanical platform holding a fluid perfusion pump, a perfusion pumping assembly, an electronic microcontroller controlling these assemblies, or combinations of these assemblies, or numerous other assemblies that have not been stated. See MPEP §§ 2163.03(V) “Original Claim Not Sufficiently Described” and 2173.04 “Breadth Is Not Indefiniteness”, which explains provisions for lack of support due to undue breadth. The Examiner suggests “the perfusion pump assembly” which has written description (specification, paragraph [0065]).
Claims 2, 3, 5-13 and 16 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 claims 2-3 and 5, the claims recite the limitation “the support assembly” in lines 2, 2, and 1-2, respectively. There is insufficient antecedent basis for this limitation in the claims.
Regarding claims 6-13 and 16, dependent claims 6 recite the limitation “a fluid reservoir … associated with the perfusion of the tissue”. However, it is unclear if this is the same fluid reservoir as the one claimed in independent claim 1 “a perfusate reservoir … to perfuse the tissue”. Regarding the dependent claims 7-13 and 16, these claims are rejected for the same reason as the base claim upon which they depend.
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.
Claims 1-2, 4, 6-11, and 13-17 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Brassil (US 20040224298) (previously cited in the IDS from 05/01/2024 and previously cited by the Written Opinion of the International Searching Authority from 08/22/2023); or, alternatively, under 35 U.S.C. 103 as obvious over Brassil (US 20040224298) (previously cited in the IDS from 05/01/2024 and previously cited by the Written Opinion of the International Searching Authority from 08/22/2023).
Regarding claim 1, Brassil discloses a support platform (paragraph [0084]; Figs. 19-23) for maintaining a tissue (paragraph [0015] “restoring viability of the organ”), comprising:
a tissue container (paragraphs [0072]-[0076], Figs. 2, 11A-11D, and 17-18A, element 65 “cassette”) for receiving the tissue (paragraph [0065] “one or more organs”);
a perfusate reservoir (Fig. 11D or Fig. 25; paragraphs [0076]-[0078] and [0081] and Fig. 18A, reservoir feeding element 1810 “venous outflow sampler” or Fig. 21) in a bottom portion of said tissue container (paragraphs [0072]-[0076], Figs. 2, 11A-11D, and 17-18A, element 65 “cassette”);
at least one perfusion loop (paragraphs [0065] and [0089]; Figs. 2 and 21 contain a perfusion loop) operably coupled to perfuse the tissue (paragraph [0090]);
a perfusion pump assembly (paragraphs [0089]-[0090]; Fig. 21, pressure transducer 2120 is used to monitor infusion pressure, a pump 2010 drives perfusion, an electronic pump controller, valves, flow sensors, pressure transducers, bubble traps, bubble detectors among other features) engaging with the perfusate reservoir (Fig. 25; paragraphs [0076]-[0078] and [0081] and Fig. 18A, reservoir feeding element 1810 “venous outflow sampler” or Fig. 21) and the at least one perfusion loop (paragraph [0089]; Fig. 21 contains a perfusion loop) to drive the perfusion loop and control (paragraphs [0089]-[0090]; Fig. 21, control through a pump 2010 that drives perfusion, an electronic pump controller, and valves, among other features) perfusion of the tissue (paragraph [0090]).
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Brassil, Fig. 11D
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Brassil, Fig. 25
If it is deemed necessary to provide motivation to combine embodiments, in the analogous art of organ apparatuses, it would have been obvious to one skilled in the art before the effective filing date to modify one embodiment of Brassil (Figs. 11A-11D) with another embodiment of Brassil (Fig. 18A) in order to collect medical fluid expelled from the organ which has collected in the bottom of the reservoir to be pumped out through tubing for filtration and returned to the organ bath or returned for recirculation (Brassil, paragraph [0106]).
Regarding the preamble, the preamble contains the term “for maintaining a tissue”. A preamble merely indicates the intended use of the apparatus and does not add structural limitations to the claims. MPEP § 2111.02(II). 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 prior art device would be fully capable of operating in this manner given its structure.
Regarding claim 2, Brassil discloses wherein at least one of the tissue container, the at least one perfusion loop and the support assembly are disposable (paragraphs [0075]-[0076] “a single-use disposable cassette”, “tubeset”, and “removable organ chair”, respectively, Fig. 2, elements 65, 400, and 1800).
Regarding the claim, the term “disposable” is intended use. The manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The prior art device would be fully capable of operating in this manner given its structure.
Regarding claim 4, Brassil discloses wherein the tissue container and the at least one perfusion loop are disposable (paragraphs [0075]-[0076] “a single-use disposable cassette” and “tubeset”, respectively, Fig. 2, elements 65 and 400).
Regarding the claim, the term “disposable” is intended use. The manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The prior art device would be fully capable of operating in this manner given its structure.
Regarding claim 6, Brassil discloses the tissue container (paragraphs [0072]-[0076], Figs. 2, 11A-11D, and 17-18A, element 65 “cassette”) further comprising:
walls (paragraph [0073]) forming an enclosure (paragraph [0073]);
a tissue platform (paragraph [0073] “organ supporting surface” and Figs. 11A-11D, element 66 or Fig. 18A element 1800 “organ chair”) within the enclosure (paragraph [0073]), the tissue platform receiving and supporting the tissue (paragraph [0073]); and
a fluid reservoir (paragraphs [0076]-[0078] and [0081] and Fig. 18A, reservoir feeding element 1810 “venous outflow sampler” or Fig. 21) within the enclosure to receive and contain fluids associated with the perfusion of the tissue (paragraph [0078]).
If it is deemed necessary to provide motivation to combine embodiments, in the analogous art of organ apparatuses, it would have been obvious to one skilled in the art before the effective filing date to modify one embodiment of Brassil (Figs. 11A-11D) with another embodiment of Brassil (Fig. 18A) in order to collect medical fluid expelled from the organ which has collected in the bottom of the reservoir to be pumped out through tubing for filtration and returned to the organ bath or returned for recirculation (Brassil, paragraph [0106]).
If it is deemed that the “fluid reservoir” above is not met by Brassil (see 35 U.S.C. § 112(b) rejection above), mere duplication of parts has no patentable significance unless a new and unexpected result is produced. MPEP § 2144.04(VI)(B). It would have been obvious to one skilled in the art before the effective filing date to modify the fluid reservoir of Brassil with an additional fluid reservoir in order to collect medical fluid expelled from the organ which has collected in the bottom of the reservoir to be pumped out through tubing for filtration and returned to the organ bath or returned for recirculation (Brassil, paragraph [0106]).
Regarding claim 7, Brassil discloses the tissue platform (Fig. 18A element 1800 “organ chair”) further comprising:
a plurality of surfaces (Fig. 18A element 1800 “organ chair”; paragraphs [0076]-[0078] and [0081] or Fig. 21).
Regarding claim 8, Brassil discloses wherein the perfusion loop (paragraphs [0065] and [0089]; Figs. 2 and 21 contain a perfusion loop) is in fluid communication with the fluid reservoir (paragraphs [0076]-[0078] and [0081] and Fig. 18A, reservoir feeding element 1810 “venous outflow sampler” or Fig. 21).
If it is deemed necessary to provide motivation to combine embodiments, in the analogous art of organ apparatuses, it would have been obvious to one skilled in the art before the effective filing date to modify one embodiment of Brassil (Figs. 2 and/or 21) with another embodiment of Brassil (Fig. 18A) in order to collect medical fluid expelled from the organ which has collected in the bottom of the reservoir to be pumped out through tubing for filtration and returned to the organ bath or returned for recirculation (Brassil, paragraph [0106]).
Regarding claim 9, Brassil discloses wherein the perfusion loop is operably coupled to an artery of the tissue (paragraphs [0079]-[0080]).
Regarding claim 10, Brassil discloses wherein the perfusion loop circulates the fluids from the fluid reservoir into the artery to perfuse the tissue (paragraphs [0079]-[0080] and [0106]), the fluids exiting a vein of the tissue and returning to the fluid reservoir (paragraph [0078] and [0106]).
Regarding claim 11, Brassil discloses further comprising:
at least one enclosure connector (paragraphs [0073] and [0078] and Fig. 11D, element 64 “connection device(s)”) configured to operably couple the tissue platform to the fluid reservoir (Fig. 11D, element 64 connects to elements 81 “tubing” and paragraph [0106]);
at least one perfusion connector (paragraphs [0073] and [0078] and Fig. 11D, element 64 “connection device(s)”) configured to operably couple the tissue with a perfusion loop, the perfusion loop perfusing the tissue (Fig. 11D, element 64 connecting to 50c and paragraphs [0079] and [0099]); and
at least one output connector (Fig. 11D, element 64 connecting to 91) configured to operably couple the tissue with an output fluid route, the output fluid route receiving an output from the tissue (paragraph [0078] “cannulating a vein”).
Regarding claim 13, Brassil discloses wherein the tissue platform, the at least one enclosure connector, the at least one perfusion connector, and the at least one output connector comprise a geometry tailored for a specific tissue (Fig. 11D and paragraph [0023] “adapted to more complex organs, such as the liver”).
Regarding claim 14, Brassil discloses further comprising:
structures in the tissue container for management of tubing to support the tubing away from the tissue (Fig. 11D, elements 63 “opening(s) for tubing … [which] may include seals 63a (e.g. septum seals or o-ring seals) and optionally be provided with plugs (not shown) to prevent contamination of the organ and maintain a sterile environment”).
Regarding the limitation “cabling and/or tubing”, the phrase is claimed in the alternative. No further rejections are needed at this time, as the limitation has been fulfilled by Brassil above.
Regarding claim 15, Brassil discloses wherein the structures for management of tubing are cutouts (Fig. 11D, elements 63 “opening(s) for tubing … [which] may include seals 63a (e.g. septum seals or o-ring seals) and optionally be provided with plugs (not shown) to prevent contamination of the organ and maintain a sterile environment”).
Regarding the limitation “cabling and/or tubing”, the phrase is claimed in the alternative. No further rejections are needed at this time, as the limitation has been fulfilled by Brassil above.
Regarding the limitation “wherein the structures for management of cabling and/or tubing are selected from the group consisting of: merlons, standoff features, crenellated edges, clamps, cutouts, and combinations thereof”, the phrase is claimed in the alternative. No further rejections are needed at this time, as the limitation has been fulfilled by Brassil above.
Regarding claim 16, Brassil discloses further comprising:
an air space between (paragraph [0073] “organ supporting surface 66, which is preferably formed of a porous or mesh material to allow fluids to pass therethrough”) the fluid reservoir (paragraphs [0076]-[0078] and [0081] and Fig. 18A, reservoir feeding element 1810 “venous outflow sampler” or Fig. 21) and the tissue platform (paragraph [0073] “organ supporting surface” and Figs. 11A-11D, element 66 or Fig. 18A element 1800 “organ chair”).
Regarding the limitation “an air space between the fluid reservoir and the tissue platform” 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 Brassil would be fully capable of having an air space between the at least one fluid reservoir and the tissue platform, given the removal of perfusate from the at least one fluid reservoir – especially in light of the mesh organ supporting surface which allows fluid to drain downwards to the reservoir from the tissue platform (as described in Brassil’s specification at paragraph [0073]).
Regarding claim 17, Brassil discloses further comprising:
a tissue enclosure hood (paragraph [0074] “inner lid 410 and an outer lid 420”) covering the tissue container (paragraphs [0072]-[0076], Figs. 2, 11A-11D, and 17-18A, element 65 “cassette”), the tissue enclosure hood configured with connectors (paragraph [0074] “clasp”) and seals (paragraph [0074] “inner seal” and Fig. 17A) to operably couple the tissue enclosure hood with the tissue container to protect the tissue from environmental contaminants (paragraph [0074]).
Claims 3 and 5 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as anticipated by Brassil (US 20040224298) (previously cited in the IDS from 05/01/2024 and previously cited by the Written Opinion of the International Searching Authority from 08/22/2023) as applied to claim 1; or, in the alternative, under 35 U.S.C. 103 as obvious over Brassil (US 20040224298) (previously cited in the IDS from 05/01/2024 and previously cited by the Written Opinion of the International Searching Authority from 08/22/2023) as applied to claim 1; or, in the alternative, under 35 U.S.C. 103 as obvious over Brassil (US 20040224298) (previously cited in the IDS from 05/01/2024 and previously cited by the Written Opinion of the International Searching Authority from 08/22/2023) as applied to claim 1, further in view of Martens (DE 4141129) (machine translation) (previously cited).
Regarding claim 3, Brassil discloses at least one of the tissue container (paragraphs [0072]-[0076], Figs. 2, 11A-11D, and 17-18A, element 65 “cassette”), the at least one perfusion loop (paragraphs [0067] and [0074]-[0075] “tubeset” respectively, Fig. 2, elements 65 and 400) and the support assembly (paragraphs [0089]-[0090]; Fig. 21, pressure transducer 2120 is used to monitor infusion pressure, a pump 2010 drives perfusion, an electronic pump controller, valves, flow sensors, pressure transducers, bubble traps, bubble detectors among other features).
Brassil does not disclose wherein at least one of the tissue container, the at least one perfusion loop and the support assembly are reusable.
However, regarding the claim, the term “reusable” is intended use. The manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The prior art device would be fully capable of operating in this manner given its structure.
Nevertheless, Martens discloses wherein the support assembly is reusable (paragraph [0011] and Fig. 2, element 42 “reusable blood pump”).
In the analogous art of organ maintenance and transport systems, it would have been obvious to one skilled in the art before the effective filing date to modify the support assembly of Brassil with the reuseable parts of Martens to reduce the need to dispose of components and replace them after each operation of the organ preservation platform.
Regarding the limitation, “at least one of the tissue container, the at least one perfusion loop and the support assembly are reusable”, the phrase is written in the alternative. No further rejections are needed at this time as at least one component of the phrase is rejected as above.
Regarding claim 5, Brassil discloses the support assembly (paragraphs [0089]-[0090]; Fig. 21, pressure transducer 2120 is used to monitor infusion pressure, a pump 2010 drives perfusion, an electronic pump controller, valves, flow sensors, pressure transducers, bubble traps, bubble detectors among other features).
Brassil does not disclose wherein the support assembly is reusable.
However, regarding the claim, the term “reusable” is intended use. The manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The prior art device would be fully capable of operating in this manner given its structure.
Nevertheless, Martens discloses wherein the support assembly is reusable (paragraph [0011] and Fig. 2, element 42 “reusable blood pump”).
In the analogous art of organ maintenance and transport systems, it would have been obvious to one skilled in the art before the effective filing date to modify the support assembly of Brassil with the reuseable parts of Martens to reduce the need to dispose of components and replace them after each operation of the organ preservation platform.
Claim 12 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as anticipated by Brassil (US 20040224298) (previously cited in the IDS from 05/01/2024 and previously cited by the Written Opinion of the International Searching Authority from 08/22/2023) as applied to claim 11; or, in the alternative, under 35 U.S.C. 103 as obvious over Brassil (US 20040224298) (previously cited in the IDS from 05/01/2024 and previously cited by the Written Opinion of the International Searching Authority from 08/22/2023) as applied to claim 11; or, in the alternative, under 35 U.S.C. 103 as obvious over Brassil (US 20040224298) (previously cited in the IDS from 05/01/2024 and previously cited by the Written Opinion of the International Searching Authority from 08/22/2023) as applied to claim 11, further in view of Franklin (US 20080145919) (newly cited).
Regarding claim 12, Brassil discloses the at least one enclosure connector (Fig. 11D, element 64 connects to elements 81 “tubing” and paragraph [0106]), the at least one perfusion connector (Fig. 11D, element 64 connecting to 50c and paragraphs [0073] and [0099]), and the at least one output connector (Fig. 11D, elements 62 and 64 connecting to 91 and paragraph [0073]).
Brassil does not disclose wherein the at least one enclosure connector, the at least one perfusion connector, and the at least one output connector comprise disposable material.
However, regarding the claim, the term “disposable” is intended use. The manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The prior art device would be fully capable of operating in this manner given its structure.
Nevertheless, Franklin discloses connections comprising disposable material (paragraph [0055] “optionally disposable after a single-use”).
In the analogous art of organ maintenance and transport systems, it would have been obvious to one skilled in the art before the effective filing date to modify the connectors of Brassil to be disposable as in Franklin in order to reduce risk of contamination.
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 18-19 and 21-22 are rejected under 35 U.S.C. 103 as obvious over Brassil (US 20040224298) (previously cited in the IDS from 05/01/2024 and previously cited by the Written Opinion of the International Searching Authority from 08/22/2023) as applied to claim 17, in view of Alastrué Vera (EP 3569064) (previously cited in the IDS from 05/01/2024 and previously cited by the Written Opinion of the International Searching Authority from 08/22/2023).
Regarding claim 18, Brassil discloses the tissue enclosure (paragraph [0065]; Fig. 1, element 2, “housing”) or container (paragraphs [0072]-[0076], Figs. 2, 11A-11D, and 17-18A, element 65 “cassette”) further comprising:
at least one sensor (paragraphs [0075], [0086], and [0097]) configured to collect sensor data about the tissue; and
at least one mounting device configured to position the at least one sensor within a pre- selected range of the tissue (paragraphs [0075], [0086], and [0097], especially [0075] “apparatus 1 or cassette 65 may be wired and fitted with a video camera … to record the progress and status of the organ”).
Brassil does not explicitly disclose the tissue enclosure hood further comprising:
at least one sensor configured to collect sensor data about the tissue;
and at least one mounting device configured to position the at least one sensor within a pre- selected range of the tissue.
Alastrué Vera discloses the tissue enclosure hood (Fig. 2, element 5, part of element 1 “container”) further comprising:
at least one sensor configured to collect sensor data about the tissue (paragraph [0050]);
and at least one mounting device configured to position the at least one sensor within a pre-selected range of the tissue (Fig. 2, element 4 “camera” is mounted to the lid of element 1 “container”; also, paragraphs [0053]-[0054] “positioning of the cameras (4) must ensure a good organ (8) visibility”).
In the analogous art of organ perfusion devices, it would have been obvious to one skilled in the art before the effective filing date to modify the tissue enclosure hood of Brassil with the tissue enclosure hood with the at least one sensor and its mounting device of Alastrué Vera in order to transmit or stream images or video to a control unit that can assess the working parameters of how to perfuse the organ (Alastrué Vera, paragraphs [0050]-[0051]).
Regarding the claim, the limitation “configured to collect sensor data about the tissue” is intended use. The manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The prior art device would be fully capable of operating in this manner given its structure.
Regarding claim 19, Brassil discloses wherein the at least one sensor comprises a wired sensor (paragraph [0075] “apparatus 1 or cassette 65 may be wired and fitted with a video camera … to record the progress and status of the organ”).
Regarding claim 21, Brassil discloses the at least one sensor (paragraph [0075]) and the tissue container (paragraphs [0072]-[0076], Figs. 2, 11A-11D, and 17-18A, element 65 “cassette”).
Brassil does not disclose wherein the at least one mounting device is configured to mount the at least one sensor outside the tissue container.
Alastrué Vera discloses wherein the at least one mounting device (Fig. 2, element 4 “camera” is mounted to the lid of element 1 “container”; also, paragraphs [0053]-[0054] “positioning of the cameras (4) must ensure a good organ (8) visibility”) is configured to mount the at least one sensor outside (paragraph [0054]) the tissue container (paragraph [0054], Fig. 2, element 1 “container”).
In the analogous art of organ perfusion devices, it would have been obvious to one skilled in the art before the effective filing date to modify the tissue enclosure hood of Brassil with the tissue enclosure hood with the at least one sensor and its mounting device outside the tissue container of Alastrué Vera in order to transmit or stream images or video to a control unit that can assess the working parameters of how to perfuse the organ, and to ensure sterility of the organ (Alastrué Vera, paragraphs [0050]-[0051] and [0054]).
Regarding claim 22, Brassil discloses the at least one sensor (paragraph [0075]) and the tissue container (paragraphs [0072]-[0076], Figs. 2, 11A-11D, and 17-18A, element 65 “cassette”).
Brassil does not disclose wherein the at least one mounting device is configured to mount the at least one sensor inside the tissue container.
Alastrué Vera discloses wherein the at least one mounting device (paragraph [0053] camera is inside the container and “positioning of the cameras (4) must ensure a good organ (8) visibility”) is configured to mount the at least one sensor inside (paragraph [0053]) the tissue container (paragraph [0053], Fig. 1, element 1 “container”).
In the analogous art of organ perfusion devices, it would have been obvious to one skilled in the art before the effective filing date to modify the tissue enclosure hood of Brassil with the tissue enclosure hood with the at least one sensor and its mounting device inside the tissue container of Alastrué Vera in order to transmit or stream images or video to a control unit that can assess the working parameters of how to perfuse the organ, and permit close range imaging of the organ to ensure quality of the imaging (Alastrué Vera, paragraphs [0050]-[0051] and [0053]).
Claim 20 is rejected under 35 U.S.C. 103 as obvious over Brassil (US 20040224298) (previously cited in the IDS from 05/01/2024 and previously cited by the Written Opinion of the International Searching Authority from 08/22/2023) in view of Alastrué Vera (EP 3569064) (previously cited in the IDS from 05/01/2024 and previously cited by the Written Opinion of the International Searching Authority from 08/22/2023) as applied to claim 18, further in view of Nagar (US 20210396446) (previously cited).
Regarding claim 20, Brassil does not disclose wherein the at least one sensor comprises a wireless sensor.
Nagar discloses wherein at least one sensor comprises a wireless sensor (paragraph [0103]).
In the analogous art of devices for controlling environmental conditions of substances, it would have been obvious to one skilled in the art before the effective filing date to modify the sensor of modified Brassil to be a wireless sensor as in Nagar in order to transmit or stream images or video analyzing the contained substance to an external device (Nagar, paragraph [0103]).
Claim 23 is rejected under 35 U.S.C. 103 as obvious over Brassil (US 20040224298) (previously cited in the IDS from 05/01/2024 and previously cited by the Written Opinion of the International Searching Authority from 08/22/2023) in view of Alastrué Vera (EP 3569064) (previously cited in the IDS from 05/01/2024 and previously cited by the Written Opinion of the International Searching Authority from 08/22/2023) as applied to claim 18, alone or further in view of Kono (JP H01308201) (machine translation) (previously cited).
Regarding claim 23, Brassil discloses wherein the at least one sensor provides the sensor data to at least one controller (paragraph [0075] “captured images may be made available over a computer network…”), being configured to present the sensor data (paragraph [0075] “additional data analysis and remote monitoring”).
If it is deemed that Brassil does not disclose the at least one controller driving a display (a monitor, for instance, being a common computer component), the display being configured to present the sensor data (a monitor presenting sensor data), Kono discloses wherein the at least one sensor (pg. 3, top of page “television camera 7”) provides sensor data (pg. 3, top of page “signal line”) to at least one controller (pg. 3, top of page “processed by a signal processing section 10 in the control section 3”) driving a display (pg. 3, top of page “monitor 11”), the display being configured to present the sensor data (abstract and pg. 3, top of page “displayed on a monitor 11”).
In the analogous art of organ storing equipment, it would have been obvious to one skilled in the art before the effective filing date to modify the at least one sensor and the at least one controller of Brassil to present sensor data on a display as in Kono in order to determine the state of the stored organ 4 from color of the organ (Kono, abstract).
Response to Arguments
Applicant’s arguments filed 12/22/2025 have been fully considered but they are not persuasive.
Regarding Applicant arguments, pg. 8 of 12, Brassil’s “cassette” (Fig. 17-18A, element 65) reads on a tissue container of claim 1. Because the cassette of Brassil contains a tissue (paragraph [0072] “An organ chamber 40 is provided which supports a cassette 65, as shown in FIG. 2, which holds an organ to be perfused”), it is a tissue container.
The claim 1 limitation “a perfusate reservoir in a bottom portion of said tissue container” can be accurately described using a limitation already present in dependent claim 6 “a fluid reservoir (paragraphs [0076]-[0078] and [0081] and Fig. 18A, reservoir feeding element 1810 “venous outflow sampler” or Fig. 21) within the enclosure to receive and contain fluids associated with the perfusion of the tissue (paragraph [0078])”; or it can be rejected under a new Brassil citation: the bottom compartment in Fig. 11D or Fig. 25. If it is meant that there should be two fluid reservoirs in the instant invention, i.e., the “perfusate reservoir” of claim 1 as well as the “fluid reservoir” of claim 6, an obvious duplication of parts is recited and the limitation is rejected accordingly.
The perfusion circuits, i.e., “a perfusion pump assembly engaging with the perfusate reservoir and the at least one perfusion loop to drive the perfusion loop and control perfusion of the tissue” recited in claim 1, do not need to be located in the actual tissue container, and can be located externally as claim 1 is currently written. The perfusion pump assembly is part of the “support platform for maintaining a tissue” (instant claim 1). Thus, the recited limitation, “a perfusion pump assembly” is rejectable under Brassil’s paragraphs [0089]-[0090]; Fig. 21, pressure transducer 2120 is used to monitor infusion pressure, a pump 2010 drives perfusion, an electronic pump controller, valves, flow sensors, pressure transducers, bubble traps, bubble detectors among other features.
In terms of engaging the perfusion pump assembly with the reservoir, Brassil’s paragraph [0089]-[0090] and Fig. 23 provide evidence that the pump is engaging the perfusate in the reservoir through tubing.
Applicant’s arguments about the interpretation of the word “engaging” does not limit broadest reasonable interpretation of the current claim language, and no further specific definition was found for the term in the specification. Furthermore, the reservoir of Figs. 11D, 18, and 18A describe a reservoir that engages a perfusion pump via tubing 82, as seen in Fig. 25.
Regarding the dependent claims, these claims are rejected as the independent claim is still rejected and no further arguments were made regarding the dependent claims.
Conclusion
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.
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/N.G.E./Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799