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 .
Applicant’s Response
In Applicant’s response dated 5/19/26, the Applicant argued Claims previously rejected in the Office Action dated 1/27/26. Claims 1-4, 7-9 and 22-25 are pending examination.
In light of the Applicant’s amendments and remarks, the 35 USC 102 rejections have been withdrawn.
Claim Rejections - 35 USC § 103
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.
Claims 1-4, 7-9 and 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over Madsen et al., “Ex Vivo Human Placenta Perfusion, Metabolic and Functional Imaging for Obstetric Research—A Feasibility Study” (hereinafter “Madsen”), in view of Fujita et al., United States Patent Publication 2012/0161770 A1 (hereinafter “Fujita”).
Claim 1:
Madsen discloses:
A system for perfusing an ex vivo placenta to be imaged using a magnetic resonance imaging (MRI) device (see abstract and page 2, “Magnetic Resonance Imaging), the system comprising:
a chamber configured to house the ex vivo placenta therein, wherein the chamber comprises a first portion and a second portion, and a first partition separating the chamber into the first portion, wherein the ex vivo placenta is housed at least partially in the first portion (see page 2, figure 1, “Magnetic Resonance Imaging” Section). Madsen teaches a chamber configured to house the ex vivo placenta in the portion and another part of the system; and
at least one radio frequency (RF) coil disposed in the second portion and configured to detect MR signals generated, at least in part, by the ex vivo placenta when present in the chamber during imaging performed by the MRI device (see page 2, figure 1, “Magnetic Resonance Imaging” Section). Madsen teaches Imaging was performed on a 3 T Signa HDx MRI scanner (GE Healthcare, Milwaukee, WI) equipped with a 2 element 1 H array coil (GE Healthcare) and Clamshell 13C transmit coil (Rapid Biomedical GmbH, Rimpar, Germany). The perfusion chamber with the placenta was placed in the scanner isocenter such that the middle of the organ coincided with the radiofrequency center of both coils; and
at least one first inlet disposed in the second portion for receiving at least one first tube, the at least one first tube being configured to pass through at least part of the second portion to couple at least one first pump to a compartment of the ex vivo placenta when present in the chamber (see page 2, figure 1, “Magnetic Resonance Imaging” Section). Madsen teaches an inlet in a portion connected to the chamber for receiving a tube pumps fluid to a portion of the placenta.
Madsen fails to expressly disclose a perfusion chamber with a first portion and second portion separating the organ.
Fujita discloses:
a chamber configured to house the ex vivo placenta therein, wherein the chamber comprises a first portion and a second portion, and a first partition separating the chamber into the first portion and a second portion, wherein the ex vivo placenta is housed at least partially in the first portion (see figure 2, and paragraph [0025]). Fujita teaches a chamber configured to house the human organ separately from the mri elements used for imaging; and
at least one radio frequency (RF) coil disposed in the second portion and configured to detect MR signals generated (see figure 2, paragraph [0025] and claim 4). Fujita teaches one or more NMR elements comprising a radio frequency (RF) coil that is stored separately from the organ.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Madsen to include a separate part of the apparatus for storing the organ and the RF coils for the purpose of protecting the organs from the radio frequency, as recited in the claims.
Claim 2:
Madsen discloses:
at least one second inlet disposed in the first portion for receiving at least one second tube, the at least one second tube being configured to couple at least one second pump to a maternal compartment of the ex vivo placenta when present in the chamber (see page 2, figure 1, “Magnetic Resonance Imaging” Section). Madsen teaches an inlet disposed in the first portion for the placenta receiving fluid.
Claim 3:
Madsen discloses:
further comprising the at least one first tube and the at least one first pump (see figure 1). Madsen teaches a tube and a pump.
Claim 4:
Madsen discloses:
further comprising the at least one second tube and the at least one second pump (see figure 1). Madsen teaches multiple tubes and multiple pumps.
Claim 7:
Madsen discloses:
the at least one first pump is configured to pump a first solution to the fetal compartment of the ex vivo placenta through the at least one first tube; and the at least one second pump is configured to pump a second solution to the maternal compartment of the ex vivo placenta through the at least one second tube (see figure 1 and description). Madsen teaches 2 pumps to pump two solutions.
Claim 8:
Madsen discloses:
at least one third tube coupled to an injector at a first end and to the at least one first tube and/or the at least one second tube at least one second end (see page 2, figure 1, “Magnetic Resonance Imaging” Section). Madsen teaches a tube used for injecting at the first end.
Claim 9:
Madsen discloses:
wherein the injector comprises an oxygenator for oxygenating the first and/or second solutions (see page 2, figure 1, “Magnetic Resonance Imaging” Section). Madsen teaches an oxygenator for the solutions.
Claim 22:
Madsen discloses:
A system for magnetic resonance imaging (MRI) compatible perfusion apparatus comprising (see abstract and page 2, “Magnetic Resonance Imaging):
a chamber configured to house the ex vivo placenta therein, wherein the chamber comprises a first portion, wherein the ex vivo placenta, when present in the chamber, is housed at least partially in the first portion of the chamber (see page 2, figure 1, “Magnetic Resonance Imaging” Section). Madsen teaches a chamber configured to house the ex vivo placenta in the portion and another part of the system; and
at least one first inlet arranged to receive at least one first tube configure to couple to a fetal compartment of the ex vivo placenta when present in the chamber (see page 2, figure 1, “Magnetic Resonance Imaging” Section). Madsen teaches an inlet in a portion connected to the chamber for receiving to the fetal compartment;
at least one second inlet configured to receive at least one second tube configured to couple to a maternal compartment of the ex vivo placenta when present in the chamber (see page 2, figure 1, “Magnetic Resonance Imaging” Section). Madsen teaches an inlet in a portion connected to the chamber for receiving to a maternal department;
at least one radio frequency (RF) coil disposed in the second portion of the chamber and configured to detect MR signals generated, at least in part, by the ex vivo placenta when present in the chamber during MR imaging (see page 2, figure 1, “Magnetic Resonance Imaging” Section). Madsen teaches Imaging was performed on a 3 T Signa HDx MRI scanner (GE Healthcare, Milwaukee, WI) equipped with a 2 element 1 H array coil (GE Healthcare) and Clamshell 13C transmit coil (Rapid Biomedical GmbH, Rimpar, Germany). The perfusion chamber with the placenta was placed in the scanner isocenter such that the middle of the organ coincided with the radiofrequency center of both coils.
Madsen fails to expressly disclose a perfusion chamber with a first portion and second portion separating the organ.
Fujita discloses:
a chamber configured to house the ex vivo placenta therein, wherein the chamber comprises a first portion, a second portion, and a first partition separating the chamber into the first portion and a second portion, wherein the ex vivo placenta, when present in the chamber, is housed at least partially in the first portion of the chamber (see figure 2, and paragraph [0025]). Fujita teaches a chamber configured to house the human organ separately from the mri elements used for imaging; and
at least one radio frequency (RF) coil disposed in the second portion of the chamber and configured to detect MR signals generated (see figure 2, paragraph [0025] and claim 4). Fujita teaches one or more NMR elements comprising a radio frequency (RF) coil that is stored separately from the organ.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Madsen to include a separate part of the apparatus for storing the organ and the RF coils for the purpose of protecting the organs from the radio frequency, as recited in the claims.
Claim 23:
Madsen fails to expressly disclose a perfusion chamber with a first portion and second portion separating the organ.
Fujita discloses:
wherein the at least one RF coil is coupled to the chamber below the first partition (see figure 2, paragraph [0025] and claim 4). Fujita teaches one or more NMR elements comprising a radio frequency (RF) coil that is stored separately below the organ.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Madsen to include a separate part of the apparatus for storing the organ and the RF coils for the purpose of protecting the organs from the radio frequency, as recited in the claims.
Claim 24:
Madsen discloses:
further comprising: a first solution coupled to at least one first pump, the at least one first pump being coupled to the first tube; and a second solution coupled to at least one second pump, the at least one second pump being coupled to the at least one second tube, wherein the second solution is different than the first solution (see figure 1 and description). Madsen teaches 2 pumps to pump two solutions.
Claim 25:
Madsen discloses:
wherein the chamber further comprises a second partition separating the second portion from the third portion, the first portion comprises the at least one second inlet, and the third portion comprises the at least one first inlet (see figure 1 and description). Madsen multiple portions of a chamber with different inlets. This is a design choice; the same functions are being performed.
Response to Arguments
Applicant’s arguments, see REM, filed 5/19/26, with respect to the rejections of claims 1-4, 7-9 and 22-25 under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection are made in view of Madsen and Fujita.
Claim 1:
Applicants argue Madsen fails to describe a chamber configured to house the ex vivo placenta therein, wherein the chamber comprises a first portion and a second portion, and a first partition separating the chamber into the first portion and the second portion, wherein the ex vivo placenta is housed at least partially in the first portion, as recited by independent claim 1.
The Examiner agrees.
Madsen teaches a chamber configured to house the ex vivo placenta in the portion and another part of the system (see page 2, figure 1, “Magnetic Resonance Imaging” Section).
Fujita teaches a chamber configured to house the human organ separately from the mri elements used for imaging (see figure 2, and paragraph [0025]). The apparatus has multiple portions with the organ being stored in the above portion and the rf coils being stored below the organ. Thus, Madsen and Fujita teach the limitations of the claims.
Applicant argues Madsen further fails to describe at least one radio frequency (RF) coil disposed in the second portion of the chamber, as recited by independent claim 1. The Office Action (p. 3) cites to FIG. 1 of Madsen as allegedly describing this feature. While Madsen describes performing MR imaging of the placenta, Madsen does not specifically describing at least one RF coil and therefore does not describe the specific positioning of the at least one RF coil that is reflected in claim 1, namely the
positioning of the at least one RF coil in the second portion of the chamber.
The Examiner disagrees.
Madsen teaches a chamber holding the ex vivo placenta with the rf coils in a different portion to receive signals for MRI imaging. Madsen fails to teach an apparatus that houses both the chamber and the rf coils.
Fujita teaches a chamber configured to house the human organ separately from the mri elements used for imaging (see figure 2, and paragraph [0025]). FIG. 2 illustrates a kidney being held by liner. Liner may be configured to hold kidney in a fixed position or in a position that is fixed to within a tolerance so that the distances remain constant or constant to within a tolerance. Liner may be partially filled with a fluid in which the kidney is suspended or otherwise supported. Holding the kidney in this way facilitates accurately positioning the kidney in a sensitive volume produced by an NMR apparatus that will be used to perform NMR based spectroscopy of the kidney. Thus, Madsen, in view of Fujita teaches the limitations of the independent Claim.
Applicant argues Madsen also fails to describe at least one first inlet disposed in the second portion for receiving at least one first tube, the at least one first tube being configured to pass through at least part of the second portion to couple at least one first pump to a fetal compartment of the ex vivo placenta when present in the chamber, as recited by independent claim 1.
The Examiner disagrees.
Madsen teaches an inlet in a portion connected to the chamber for receiving a tube pumps fluid to a portion of the placenta (see page 2, figure 1, “Magnetic Resonance Imaging” Section).
Fujita also teaches the first connection is configured to detachably connect the organ container to a perfusion apparatus associated with the magnetic resonance apparatus. Thus, the organ transport device may be connected to one perfusion support apparatus (e.g., pump, oxygen supply) during transport and may be connected to another perfusion support apparatus after transit. In one example, the oxygen supply and/or pump may even be integrated into the MRI apparatus (see paragraph [0050]). Thus, Madsen and Fujita teach the limitations of the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIONNA M BURKE whose telephone number is (571)270-7259. The examiner can normally be reached M-F 8a-4p.
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/TIONNA M BURKE/ Examiner, Art Unit 2178 8/18/26
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