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 .
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1, in line 7, --- at least one --- should be inserted before “recess”.
Appropriate correction is required.
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.
Claim(s) 1-4, 6-11, 13 and 15 is/are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by De Man et al. (WO 2021/212118), alone, as evidenced by Leussler et al. (CN 1969195), or alternatively, in view of De Man et al. in view of Virta et al. (US Pub No. 2012/0083686). Note that the below rejection refers to the English translation of Leussler et al..
With regards to claim 1, De Man et al. disclose a diagnostic container (120, 320) for hermetically enclosing a patient during imaging with a medical imaging system (100) (paragraphs [0026]-[0027], referring to the patient isolation unit (120) which completely covers and contains the patient (110) therein and is positioned relative to the CT imaging system; paragraph [0039], referring to the patient isolation unit (320); Figures 1-3);
the container (120; Figures 1-3) comprising
an airtight shell (120, 320) configured for providing an airtight enclosure of the patient (paragraph [0027], referring to the patient isolation unit (120) which completely covers and contains the patient therein, wherein the unit (120) comprises of a base (122), first end wall (126), second end wall (128), and cover (129) which mate with one another “in a sealed configuration such that no pathogens may escape from the patient isolation unit (120) when a patient is enclosed within the patient isolation unit (120)”, and thus the container (120) is an airtight shell providing an airtight enclosure; paragraph [0033], referring to the cover being coupled to the end walls and base “to provide a substantially airtight seal”; paragraph [0039], referring to the patient isolation unit (320) which provides a “sealed configuration such that no pathogens may escape…”; Figures 1-3);
wherein the airtight shell comprises at least one recess (336) extending into an inner volume of the airtight shell, the at least one recess being configured for ensuring the airtight enclosure (paragraph [0041], referring to the built in gloves (336) formed along a length of the cover (329) of the patient isolation unit (320), wherein, as depicted in Figure 3, the gloves (336) for a recess extending into an inner volume of the airtight shell (320) and ensures the airtight enclosure as the “gloves” do not provide an opening for air to pass through; Figure 3);
wherein the recess (336) is configured for receiving a component part of a medical device and for allowing a positioning of the component part in close proximity to the patient without direct contact of the component part to the patient (paragraph [0041], Figure 3, note that the recess provided by the glove (336) is configured for receiving a component part of a medical device, such as a small instrument/sensor, as it is sized such that it is capable of receiving a small medical instrument/sensor that can fit within the hand of a user and further the gloves (336) run along the length of the patient isolation unit (320) such that any medical instrument/sensor within the gloves (336) will come into close proximity to the patient contained within the unit (320) without direct contact due to the glove surface; Examiner emphasizes that the “component part of a medical device” is not positively recited as part of the claimed diagnostic container and therefore limitations concerning the component part of a medical device are directed to an intended use or manner of operating the claimed diagnostic container. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim);
and the medical imaging system is a magnetic resonance imaging system (paragraph [0030], referring to the patient isolation unit being used with a MR imaging system) and
wherein the component part of the medical device is a body coil of the magnetic resonance imaging system (Examiner notes that the “component part of a medical device” is not positively recited as part of the claimed diagnostic container and therefore limitations concerning the component part of a medical device are directed to an intended use or manner of operating the claimed diagnostic container. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. As evidenced by Leussler et al., a body coil (40) can comprise a piece of clothing, such as a glove or mitten, all of which can be used to cover one or more regions of the patient to be imaged (Abstract; pg. 5, 4th paragraph; pg. 6, last paragraph). Therefore, the at least one recess (336) of De Man et al., which can be in the form of built in gloves (336) (paragraph [0041]) is capable of receiving a component part that is a body coil of the magnetic resonance imaging system as a body coil can comprise a glove or mitten, and therefore the at least one recess of De Man et al. formed and sized as built in gloves is capable of receiving a body coil of a magnetic resonance imaging system, such as one that is similarly sized and formed as gloves. De Man et al. therefore meets the above limitation.).
Alternatively, with regards to the limitation concerning “wherein the component part of the medical device is a body coil of the magnetic resonance imaging system”, if the at least one recess of De Man et al. is not viewed as being capable of receiving a body coil of the magnetic resonance imaging system, Virta et al. disclose an MR imaging unit (3) arranged to acquire MR signals from the portion of the body (2) and to reconstruct a MR image from the MR signals, wherein the MR imaging unit (3) comprises a RF receiving antenna/coil (14) for receiving the MR signals (Abstract; paragraphs [0012]-[0013]; Figures 2-3). The RF receiving antenna (14) may be located within a watertight casing, thus preventing water contact of the electrically conductive parts of the antenna and providing further protection against fluid contact (paragraphs [0013], [0024]; Figures 2-3). The watertight compartment may be arranged at the circumference of the treatment hole such that the RF coil located in the compartment surrounds the treatment hole (paragraphs [0013], [0024]; Figures 2-3). The watertight compartment (16) is formed by a base part (17) and a top part (18) of the enclosure of the patient table (9) as well as by a ring-shaped insert (19) defining the treatment hole (11) (paragraph [0024]; Figures 2-3, wherein as depicted in Figures 2-3, the watertight compartment (16) forms a recess in a patient table that is configured for receiving a body coil (14) of the magnetic resonance imaging system). The RF coil (14) is in this way completely hidden under the enclosure parts of the patient table (paragraph [0024]).
Therefore, alternatively, it would have been obvious to one of ordinary skill in the art to have the at least one recess of De Man et al. to include a recess that is configured for receiving the component part of the medical device comprising of a body coil of the magnetic resonance imaging system, as taught by Virta et al., in order to receive MR signals and providing protection of the body coil against fluid contact (Abstract; paragraphs [0013], [0024]). Note that in De Man et al., the patient table (224, 324) of De Man et al. is arranged inside of the airtight shell (120, 320) (see Figures 1-3 of De Man et al.), and therefore the recess formed in the patient table, as taught by Virta et al., would result in the recess of the above combined references extending into an inner volume of the airtight shell as the patient table of De Man extends into an inner volume of the airtight shell.
With regards to claim 2, De Man et al. disclose the container comprises a patient bed (224, 324) configured for receiving the patient (210), and wherein the patient bed (224) is arranged inside of the airtight shell (120, 320) (paragraphs [0030]-[0032], referring to the patient isolation unit (220) including a “low profile pad 224” which provides positioning of the patient; paragraph [0039], referring to the patient isolation unit (320) including a pad (324); Figures 1-3).
With regards to claim 3, De Man et al. disclose that the container comprises a patient bed (224, 324), wherein the airtight shell (120, 320) is configured to be connected to the patient bed (i.e. via the base 222), and wherein the airtight enclosure of the patient (210) is provided by the airtight shell (120, 320) in combination with the patient bed (224, 324) (paragraphs [0030]-[0032], referring to the patient isolation unit (220) including a “low profile pad 224” which provides positioning of the patient, wherein the pad (224) is positioned on top of base (222), wherein the base (22) mates with the walls (226, 228) and cover (229) in a sealed configuration to form the patient isolation unit (220), and therefore the base (222) [and thus the bed (224) on top of it as well] combined with the other components of the airtight shell (120, 320) provides the airtight/sealed enclosure; paragraph [0039], referring to the patient isolation unit (320) including a pad (324); Figures 1-3).
With regards to claim 4, De Man et al. disclose that the airtight shell comprises an access port, wherein the access port (430, 730, 930, 1030) comprises an opening and a seal ,wherein the access port is configured to allow insertion of a head coil of the medical imaging system through the opening to position the head coil in close proximity to the head of the patient, and wherein the seal is configured to ensure the airtight enclosure (paragraphs [0031]-[0032], referring to the components (i.e. base, walls, etc.) of the patient isolation unit being sealed, and thus the head enclosure (430, 730, 930, 1030) of the patient isolation unit would be sealed with the other components of the patient isolation unit; paragraphs [0043]-[0045], referring to the head enclosure (430, 730,930, 1030) which is coupled to the body enclosure and, as depicted in Figures 4-10, includes an opening for the head of the patient to fit through, wherein the opening is sized such that it is capable of allowing a head coil to be inserted therein; paragraph [0050]; Figures 1-10). Examiner notes that, with regards to the limitations concerning the “head coil” (i.e., access portion configured to “allow insertion of a head coil…to position the head coil…”), the head coil is not positively recited as part of the claimed container, and therefore the limitations are directed to an intended use of the claimed apparatus/container. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
With regards to claim 6, De Man et al. disclose that the container comprises an interface configured to connect the container to the medical imaging system to provide electric power supply, ventilation and/or data transfer between the container (100) and the medical imaging system (paragraphs [0036]-[0037], referring to the air filtration system (240) with an air intake filter (242) positioned at and coupled to a first end (221) of the patient isolation unit (220), an air exhaust filter positioned at a second end (223) and an air pump (226) coupled to the patient isolation unit (220), wherein the air filtration system (240) is configured to supply fresh or clear air (i.e. ventilation) to the patient isolation unit (220) and exhaust filtered air from the patient isolation unit (220); paragraph [0040], referring to the air filtration system (340); Figures 1-3).
With regards to claim 7, De Man et al. disclose that the airtight shell is a mechanical hardcover or a sliding tent roof (paragraphs [0031]-[0033], referring to the cover (229) being made of a rigid material (i.e. hardcover), wherein the cover mates with the other components (i.e. base, end walls) in a sealed configuration using strips of hook and loop fasteners, rubber zippers or any known non-metallic fastener, or, alternatively, the cover may be configured a removable roller shutter-like cover that rolls up, etc. (i.e. “sliding tent roof”); paragraph [0039]; Figures 1-3).
With regards to claim 8, De Man et al. disclose that the interface is arranged at an end of the container corresponding with the head or with the feet of the patient (paragraphs [0036]-[0037], referring to the air intake filter (242) being positioned at and coupled at a first end (221) of the patient isolation unit (220) and/or referring to air exhaust filter being positioned at and coupled to a second end (223) of the patient isolation unit (220), wherein, as depicted in Figure 2, the first and second ends (221, 223) of the patient isolation unit correspond to the feet and head of the patient; paragraph [0040]; Figures 1-3).
With regards to claim 9, De Man et al. disclose that the container comprises an optical window configured for camera-based monitoring of a vital sign of the patient through the optical window (paragraph [0032], referring to a portion of the cover being transparent to enable visual contact with the patient contained therein, and thus the transparent portion of the cover serves as an “optical window” that is capable of allowing camera-based monitoring of a vital sign of the patient through the optical window; Figures 1-3; Examiner notes that the “camera-based monitoring”/camera is not positively set forth as part of the claimed container and therefore limitations concerning the ”camera-based monitoring” is considered to be directed to an intended use and/or manner of operating the claimed container. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.).
With regards to claim 10, De Man et al. disclose that the container comprises a feedthrough that is capable of allowing an optical fiber configured to be attached to the body of the patient via a skin patch to be inserted therein (paragraph [0041], referring to the patient isolation unit (320) including covers that provide for intravenous lines, IV contrast agent lines, wherein the IV or contrast line ports (338) are capable of serving as a feedthrough for an optical fiber [configured to be attached to the body of the patient via a skin patch]; Figure 3). Examiner notes that the optical fiber that is configured to be attached to the body of the patient via a skin patch is not positively recited as part of the claimed container, and therefore the limitations directed to the optical fiber are directed to an intended use and/or manner of operating the claimed container/apparatus. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
With regards to claim 11, De Man et al. disclose that the airtight shell is made of a material with low X-ray absorption and/or low absorption for radiation for oncology therapy treatment (paragraph [0032], referring to the base (222) and walls (226, 228) of the patient isolation unit being made of low X-ray absorption material, such as carbon fiber material or a polycarbonate material [which are known in the art to have the property of being low X-ray absorption material]).
With regards to claim 13, De Man et al. disclose that the airtight shell comprises a plurality of modules (i.e. base 222, first end wall 226, second end wall 228 and cover 229), wherein the modules are configured to be connected to each other in order to provide the airtight enclosure and/or wherein the modules comprise a communication link to be connected communicationally to each other (paragraph [0031], referring to the base 222, first end wall 226, second end wall 228 and cover 229 mating with one another in a sealed configuration such that no pathogens may escape; paragraph [0039]; Figures 2-3).
With regards to claim 15, De Man et al. disclose a method comprising: providing a container (120, 320) according to claim 1 in a medical imaging system (100) [see rejection of claim 1; Figures 1-3); and imaging a patient with the medical imaging system (paragraphs [0022]-[0027], [0029]-[0030], referring to the CT imaging of the patient; Figures 1-3).
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.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over De Man et al., alone, as evidenced by Leussler et al., or in view of Virta et al., as applied to claim 1 above, and further in view of Hering (CN 103142227). Note that the below rejection refers to the English translation of Hering.
With regards to claim 12, as discussed above, De Man et al. (or the above combined references) meet the limitations of claim 1. However, De Man et al. do not specifically disclose that the container comprises a marker configured to provide an indication of a position of the patient with respect to the medical imaging system.
Hering discloses a setup shell device for setting up and/or positioning young children or babies for a medical imaging examination, wherein the supporting shell device can also have a marker element and therefore can precisely detect the support shell equipment location and/or position of the patient examining table of the medical imaging equipment (Abstract; paragraphs [0014]-[0015]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the container of De Man et al. comprise a marker configured to provide an indication of a position of the patient with respect to the medical imaging system, as taught by Hering, in order to precisely detect the container location and/or position of the patient examining table of the medical imaging equipment (paragraphs [0014]-[0015]), thereby allowing more accurate imaging of a desired target.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over De Man et al., alone, as evidenced by Leussler et al., or in view of Virta et al., as applied to claim 1 above, and further in view of Economopoulos et al. (US Patent No. 11,077,005).
With regards to claim 14, as discussed above, De Man et al. (or the above combined references) meet the limitations of claim 1. However, De Man et al. do not specifically disclose that the container comprises an airlock with a membrane, wherein the airlock is configured to allow contact imaging of the body of the patient through the membrane.
Economopoulos et al. disclose a patient isolation chamber comprising a two-way transfer chamber (27), wherein, as is known in the glove box art, such an “airlock” for example may be box-like in overall shape and have an external access door (27a) through which objects such as ultrasound probes, etc. may be deposited into an internal region (airlock) of chamber (27) or alternatively retrieved therefrom, as well as separate internal access door (27b) through which such items may be transferred from the airlock to internal, open region (24) of enclosure (10) or alternatively from region (24) to the airlock (Abstract; column 9, lines 12-26; column 10, lines 16-34, note that ultrasound probes provide contact imaging of the body of the patient; Figures 1,3). A pair of sleeves/gloves (32) are coupled to canopy drape (22) on each of sides (22a, 22e) and protrude into open region (24), wherein the sleeves/gloves (32) are configured for receiving hands and arms of a user and the sleeves are formed of a second polymeric material (i.e. membrane) and have a closed, first free end (32a) and an open, second free end (32b) (column 10, line 49-column 11, line 3; Figure 3). The sleeves/gloves (32) also permit patients to have indirect physical contact with family members or health care professionals (HCP), with potential mental health advantages and permit HCPs to measure vital signs of a patient, insert intravenous and central lines, manipulate ventilation tubes, use ultrasound equipment, and use a stethoscope (column 17, lines 16-22).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the container of De Man et al. to comprise an airlock with a membrane, wherein the airlock is configured to allow contact imaging of the body of the patient through the membrane, as taught by Economopoulos et al., in order to permit patients to have indirect physical contact with family members or health care professionals, with potential mental health advantages and permit health care professionals to measure vital signs of a patient, insert intravenous and central lines, manipulate ventilation tubes, use ultrasound equipment, and use a stethoscope (column 17, lines 16-22).
Response to Arguments
Applicant's arguments filed January 27, 2026 have been fully considered but they are not persuasive.
With regards to De Man, Applicant argues that though De Man mentions built in gloves which might help to provide for patient needs, De Man does not disclose that there might be a need for the positioning of body coils as component parts of a magnetic resonance imaging system as a medical device close to the patient, but without direct contact to the patient and with an isolation to the patient. Applicant further argues that the built-in gloves of De Man are not suitable for the positioning of a body coil of a magnetic resonance imaging system close to the patient, as at least a size and position of the provided gloves are incompatible for the requirements of positioning the respective coils close to the patient.
Examiner respectfully disagrees and first notes that the gloves/recess of De Man are in close proximity to the patient without direct contact of the component part to the patient (See Figures 1-3 of De Man), and therefore it would follow that any component part that is received in the recess would also be in close proximity to the patient, etc.. Further, Examiner notes that the “component part of a medical device” is not positively recited as part of the claimed diagnostic container of claim 1 and therefore limitations concerning the component part of a medical device are directed to an intended use or manner of operating the claimed diagnostic container. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. As evidenced by Leussler et al., a body coil (40) can comprise a piece of clothing, such as a glove or mitten, all of which can be used to cover one or more regions of the patient to be imaged (Abstract; pg. 5, 4th paragraph; pg. 6, last paragraph). Therefore, the at least one recess (336) of De Man et al., which can be in the form of built in gloves (336) (paragraph [0041]) is capable of receiving a component part that is a body coil of the magnetic resonance imaging system as a body coil can comprise a glove or mitten, and therefore the at least one recess of De Man et al. formed and sized as built in gloves is capable of receiving a body coil of a magnetic resonance imaging system, such as one that is similarly sized and formed as gloves (which does exist as evidenced by Leussler et al.). De Man et al. therefore meets the above limitation.
Applicant further asserts that De Man focuses on computer tomography systems and intends to make the patient isolation unit radiation transparent.
However, paragraph [0030] of De Man sets forth “Although a CT imaging system is shown and described by way of example in FIG. 1, it should be understood that the patient isolation unit may also be used with other imaging systems, such as…a MR imaging system, and combinations thereof (e.g., multi-modality imaging systems, such as PET/CT, PET/MR or SPECT/CT imaging systems). The present discussion of a CT imaging system is provided merely as an example of one suitable imaging modality”. Therefore, the invention of De Man is not limited to a computer tomography system and De Man explicitly discloses that the imaging system may be a “MR imaging system”, wherein in such a system it would be reasonable for body coils to be used.
Examiner notes that the claims remain rejected as anticipated by De Man. However, if Applicant does not view that the recess of De Man is at least capable of receiving the component part in the form of a body coil, an alternative rejection is provided above, wherein the claims are alternatively rejected under De Man in view of Virta.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE L FERNANDEZ whose telephone number is (571)272-1957. The examiner can normally be reached Monday-Friday 9:00 AM - 5:30 PM (ET).
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/KATHERINE L FERNANDEZ/Primary Examiner, Art Unit 3798