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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 25, 2026 has been entered.
Claim Objections
Claims 1, 15-16, 19 and 21 are objected to because of the following informalities:
In claim 1, in lines 8 and 9, --- at least one --- should be inserted before “recess”.
In claim 15, in lines 3 and 4, --- at least one --- should be inserted before “recess”.
In claim 16, in line 1, --- at least one --- should be inserted before “recess”.
In claim 19, in line 1, --- at least one --- should be inserted before “recess”.
In claim 21, in line 2, “a magnetic” should be changed to --- the magnetic ---.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4 and 6-21 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.
Claim 1 recites the limitation "the component part" in line 9. There is insufficient antecedent basis for this limitation in the claim.
With regards to claim 1, in line 10, it is unclear as to whether the “a component part” is referring to the same “the component part” in line 9, or referring to a different structure. For examination purposes, Examiner assumes the former.
With regards to claim 15, in line 2, it is unclear as to whether the “a medical imaging system” is referring to the same “medical imaging system” set forth in line 2 of claim 1, or referring to a different system. For examination purposes, Examiner assumes the former.
With regards to claim 18, it is unclear as to whether the “a first recess” and “a second recess” recited in lines 1-2 is referring to ones of the “plurality of recesses” set forth in claim 17 or referring to separate, distinct “recesses”. For examination purposes, Examiner assumes the former.
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, 15-19 and 21 is/are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as anticipated by De Man et al. (WO 2021/212118), as evidenced by Leussler et al. (CN 1969195) or, in the alternative, under 35 U.S.C. 103 as obvious over De Man et al. in view of Virta et al. (US Pub No. 2012/0083686) and Scarth et al. (US Pub No. 2009/0306494). 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 such that the recess does not breach 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) form a recess extending into an inner volume of the airtight shell (320) and do not breach the airtight enclosure as the “gloves” do not provide an opening for air to pass through; Figure 3);
wherein the at least one recess comprises airtight and closed walls on each side except an entrance side, such that an airtight wall of the recess is positioned between the component part received in the recess and the patient (paragraph [0041], referring to the “built in gloves 336) formed along a length of the cover (329) of the patient isolation unit, wherein it is clear that the “gloves”/recess provides airtight and closed walls on each side except an entrance side (i.e. open side of the gloves); paragraphs [0027], [0039], referring to the patient isolation unit (120; i.e. airtight shell) completely covering and containing the patient therein, wherein the unit comprises a base (122), first end wall (126), etc., 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); paragraph [0033], referring to the cover coupled to the end walls and base of the patient isolation unit provides "a substantially airtight seal", and thus the patient isolation unit (120) is an airtight shell providing an airtight enclosure, and therefore it follows that the "built in” gloves 336 (i.e.whose surfaces forms walls on each side except side (i.e. “entrance side”) wherein hands could be inserted), which are formed along the length of the cover of the patient isolation unit would also ensure that no pathogens escape from the patient isolation unit in order to ensure that the patient isolation unit (120) maintains the "sealed"/airtight configuration; see Figure 3, wherein it is clear that the surfaces of the gloves (i.e. “airtight wall of the recess”) are positioned between any component part [that can be received in the recess] and the patient; note that claim 1 is directed to “A diagnostic container”, wherein “the component part” is not positively recited as part of the claimed container and thus “the component part” is viewed as a structure that is to be used with the claimed container [Further note that the last two lines of claim 1 sets forth that the “component part…is a body coil of the magnetic resonance imaging system”, wherein the first two lines of claim 1 sets forth “A diagnostic container for hermetically enclosing a patient during imaging with a medical imaging system”, and therefore the diagnostic container is separate from the medical imaging system, including the “component part” of the medical imaging system]. 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);
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 and thus an airtight wall of the recess is also not viewed as being positioned between the component part received in the recess and the patient:
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], note that a “watertight casing” is inherently sealed and thus is further “airtight” ; 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, wherein the at least one recess (16) comprises airtight and closed walls on each side such that an airtight/sealed wall of the recess is positioned between a component part (14) received in the recess and the patient). The RF coil (14) is in this way completely hidden under the enclosure parts of the patient table (paragraph [0024]).
Therefore, in the alternative rejection, 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, wherein the at least one recess comprises airtight and closed walls on each side, such that an airtight wall of the recess is positioned between the component part received in the recess and the patient, 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.
However, in the above alternative rejection in further view of Virta et al., the above combined references do not specifically disclose that the at least one recess comprises an entrance side that is not airtight.
Scarth et al. disclose a patient table for a common imaging system including Magnetic Resonance and X-ray retaining the patient stationary in position prior to, during and subsequent to the imaging, wherein, when the imaging is to be of the chest, an anterior chest coil (31) is arranged to be placed on top of the chest of the patient when in place for imaging on the mattress (i.e. patient support) and also the posterior coil (32) is arranged to be inserted into a receptacle (27) of the patient support (Abstract; paragraphs [0141]-[0142], [0144]; Figure 4). In order to protect the coil 32 and in order to ensure that the mattress remains properly flat over the receptacle 27, a flat rectangular sleeve 33 is provided which is inserted in place under the mattress when the coil 32 is to be used (paragraph [0144]). The posterior coil 32 to slide into place through a slot shaped opening 34 in one side of the sleeve 33 at the side of the mattress 18 (paragraph [0144]; Figures 3-4, note that the slot shaped opening (34) forms a recess wherein an entrance side is not sealed (i.e. and thus not “airtight”) as it allows removal and insertion of the coil). The coil 32 is shaped to fit simply as a sliding fit into the interior of the sleeve (paragraph [0144]). Thus when it is intended to carry out magnetic resonance imaging, the posterior coil 32 can simply slide into place allowing the patient and the cantilever portion of the table to slide into the magnetic bore to carry out the imaging (paragraph [0144]). When the imaging is complete and the patient is to be imaged by an X-Ray system, the coil 32 can simply be removed by pulling the coil out of the opening 34 of the sleeve 33 (paragraph [0145]). The anterior coil 31 can also simply be removed from the top of the patient chest so that all coil portions are removed from the table allowing X-Ray imaging to be carried out without any interference from any metal components in the table (paragraph [0145]). Coil integration can involve a slot or a cavity within the tabletop itself, or within the tabletop mattress, wherein the coils, such as head coils and cardiac coils, can be positioned and removed without moving or shifting the patient in any way (paragraph [0161]).
Therefore, in the alternative rejection, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the at least one recess of the above combined references comprise an entrance side that is not airtight, as taught by Scarth et al., in order to provide simple insertion and removal of a coil, thereby allowing the system to be used for different imaging purposes (paragraphs [0144]-[0145]).
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).
With regards to claim 16, as discussed above, the above combined references meet the limitations of claim 1. However, the above combined references do not specifically disclose that the recess is formed as a channel or a tunnel reaching through the entire inner volume of the diagnostic container. Scarth et al. disclose a receptacle/recess (27) formed as a channel/tunnel reaching through the entire inner volume of a patient table, wherein the receptacle/recess (27) (paragraphs [0144], Figure 3-5, note that the recess (27), as depicted in Figure 5, extends through the entire inner volume width of the patient support, wherein in De Man et al., such a receptacle/recess extending through the entire inner volume width of the patient support (see Figures 1-3 of De Man et al.)). Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the recess of the above combined references be formed as a channel or a tunnel reaching through the entire inner volume of the diagnostic container, as taught by Scarth et al., in order to provide simple insertion and removal of a coil, thereby allowing the system to be used for different imaging purposes (paragraphs [0144]-[0145]).
With regards to claim 17, De Man et al. disclose that the container comprises a plurality of recesses (336) at different locations of the container and/or with different sizes (see Figure 3).
With regards to claim 18, De Man et al. disclose that a first recess is configured to position an MRI coil and a second recess is configured to position a vital signs monitor (With regards to the first recess being configured to position an MRI coil, see rejection of claim 1 which sets forth that the at least one recess (i.e. “first recess”) is configured for receiving a component part, wherein the component part is “a body coil of the magnetic resonance imaging system”, which corresponds to “an MRI coil”; With regards to the second recess, Examiner notes that the “vital signs monitor” is not positively set forth as part of the claimed container and therefore limitations concerning the ”vital signs monitor” 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. Since the “gloves”/recesses of De Man et al. are sized such that they are capable of receiving a vital signs monitor (i.e. such as electrodes, etc.), De Man et al. meet the limitation).
With regards to claim 19, Scarth et al. disclose that the recess is configured to be opened and closed using a zipper or a shutter (paragraph [0144], referring to the sleeve (33) which serves as a shutter (i.e. a movable cover, slide for an opening) for the receptacle (27), wherein, as depicted in Figures 5-7, removing and inserting the sleeve allows the recess (27) to be opened and closed; Figures 5-7).
With regards to claim 21, De Mann et al. disclose that the container is compatible with both a magnetic resonance imaging system and an X-ray or CT system such that the patient can be imaged in both systems consecutively without opening or changing the container (paragraph [0027], referring to the patient isolation unit (120) comprise of a pathogen impermeable material compatible with one or more of radiation imaging systems and magnetic resonance (MR) imaging systems). Scarth et al. also discloses this limitation (see Abstract and paragraphs [0160]-[0161] of Scarth et al., referring to the patient table being completely MR and X-ray compatible, wherein coil integration can involve a slot or cavity within the tabletop itself, or within the tabletop mattress).
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. and Scarth 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. and Scarth 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).
Claim(s) 20 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. and Scarth et al.as applied to claim 4 above, and further in view of Rapoport (US Pub No. 2020/0383602).
With regards to claim 20, as discussed above, the above references meet the limitations of claim 4. However, the above combined references do not specifically disclose that the access port is configured to allow a linear movement of the head coil toward the patient to adjust a distance between the head coil and the head of the patient, the distance being in a range of 5 mm to 10 cm.
Rapoport discloses a maneuverable RF coil assembly useful for being maneuvered at positions over at least a portion of a neonate immobilized with a cradle at the time of MR imaging, wherein the maneuvering mechanism comprises a linear reciprocating mechanism for approaching or otherwise drawing away at least one coil to and from the neonate (Abstract; paragraphs [0648]-[0649]; Figure 9A). The plurality of RF coil assemblies can be maneuvered along the track of the sliding mechanism (125) in a reciprocating linear motion along the arrow B and contrariwise, and in a tilting motion along the arrow (A), to a closed position at least partially over a neonates head as in FIG. 9A, or at least one open position as in FIG. 9B away from the neonate's head (e.g. below the cradle) (paragraph [0649]; Figures 9A,B). The invention addresses the long felt need of providing a maneuverable RF coil and methods for both (i) applying an RF coil over a neonate immobilized within his/her cradle and (ii) conveniently removing the RF coil from the neonate and safely placing it when it is not required for imaging (paragraph [0024]).
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 access port of the above combined references be configured to allow a linear movement of the head coil toward the patient to adjust a distance between the head coil and the head of the patient, as taught by Rapoport, in order to provide a maneuverable RF coil and methods for both (i) applying an RF coil over a patient immobilized within the container and (ii) conveniently removing the RF coil from the patient and safely placing it when it is not required for imaging (paragraph [0024]).
The above combined references do not specifically disclose the distance being in a range of 5 mm to 10 cm. However, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art, through routine optimization, to adopt the claimed distance being in a range of 5 mm to 10 cm, in order to determine the optimal distance which provides a desired position of the head coil optimized for the patient.
Response to Arguments
Applicant's arguments filed June 25, 2026 have been fully considered but they are not persuasive.
With regards to De Man, Applicant argues that the glove features for line management and patient access, not a recess as specifically claimed having airtight and closed walls on each side except an entrance side for receiving and positioning an MRI body coil while maintaining an airtight wall between the coil and patient.
However, Examiner respectfully disagrees that the disclosed “gloves” of De Man are for line management and patient access. Paragraph [0041] sets forth “In an exemplary embodiment, to provide for ease in patient access during use, the patient isolation unit 320 may include optional and/or alternative covers that provide for intravenous (IV) lines, IV contrast agent lines, and one or more built in gloves 336 formed along a length of the cover 329.” De Man therefore sets forth that their device includes optional covers that provide the IV lines, IV contrast agents lines, etc., and, separately, also include gloves 336 formed along a length of the cover 329. The gloves of De Man are therefore not access/line-management features and instead part of the airtight shell. Specifically, DeMan discloses in paragraph [0041] that "built in gloves 336" are formed along a length of the cover (329) of the patient isolation unit, wherein it is clear that the "gloves"/recess ensures the airtight enclosure as the gloves do not provide an opening for air to pass through. Examiner emphasizes that DeMan discloses in paragraphs [0027] and [0039] that the patient isolation unit (120, i.e. airtight shell) completely covers and contains the patient therein, wherein the unit comprises a base (122), first end wall (126), etc., 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 paragraph [0033] further sets forth that the cover coupled to the end walls and base of the patient isolation unit provides "a substantially AIRTIGHT seal", and thus the patient isolation unit (120) is an airtight shell providing an airtight enclosure. It follows that the "BUILT IN" gloves 336 which are formed along the length of the cover of the patient isolation unit would also ensure that no pathogens escape from the patient isolation unit in order to ensure that the patient isolation unit (120) maintains the "sealed"/airtight configuration. Further, as was set forth in the rejection, the "component part of a medical device" is not positively recited as part of the claimed diagnostic container and therefore the limitations concerning the component part of the medical device are directed to an INTENDED USE OR MANNER OF OPERATING the claimed diagnostic container. Examiner respectfully refers Applicant to the above rejection for a further discussion as to how the gloves/recess of De Man are capable of receiving a component part which is a body coil of the magnetic resonance imaging system.
If the above is not found persuasive, Applicant should note the alternative rejection of De Man further in view of Virta and newly introduced Scarth. Scarth has been introduced to teach that the at least one recess of De Man in view of Virta comprises a non-airtight wall on an entrance side, etc.. It is noted that Applicant does not provide arguments with regards to previously applied Virta, and therefore Virta is maintained in the alternative rejection.
The claims remain rejected.
Conclusion
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/KATHERINE L FERNANDEZ/Primary Examiner, Art Unit 3798
