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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 19 June 2026 has been entered. Claims 1, 5, 6, and 13-15 are currently amended. Claims 1-19 are currently under examination and are pending.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 5, it recites the limitation “the jackets”. There is insufficient antecedent basis for this limitation, as “the jacket” is introduced as a singular element as stated in claim 2.
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, 3, and 11-16 are rejected under 35 U.S.C. 103 as being obvious over Hannemann (DE 102012217445 A1) in view of Kodaira (US 20150265232 A1) and further in view of McMahon et al. (US 20210298977 A1) (hereon referred as McMahon).
Regarding claim 1, Hannemann teaches an imaging system isolation enclosure ("medical device can be covered with a film", paragraph [0001]; medical device 1, housing 2, film 7, Fig. 1, Fig. 2) comprising:
A pathogen impermeable enclosure ("cover the medical device with a substantially sterile film material", paragraph [0002]; film 7, grooves 8, Fig. 1, Fig. 2, Fig. 4) for use with one or more of radiation imaging systems and magnetic resonance imaging systems, the pathogen impermeable enclosure configured to provide a barrier (paragraph [0010]; patient receiving opening 3, film 7, Fig. 1, Fig. 2) between the imaging system and at least one of a patient user and an imaging room.
Hannemann does not teach an air filtration system including an inlet to intake air into the pathogen impermeable enclosure, and an outlet to exhaust air out.
However, Kodaira teaches an imaging system isolation cover ("gantry fixing unit 60 are covered by a cover 70", paragraph [0033]; covers 70, 70-1, 70-2, 70-3, 70-4, 70-5, Fig. 5) comprising:
An air filtration system including an inlet to supply a cooling air flow to an interior of the enclosure ("plurality of inlets are formed in the lower cover 70-5", paragraph [0033], “cooling fan 29 is an exhaust fan which sends air inside the gantry 10”, paragraph [0022]; inlet 113, Fig. 9, also shown in annotated Fig. 9 below) and an outlet to output exhaust air from the interior of the pathogen impermeable enclosure ("air inside the gantry 10 is then discharged from the plurality of outlets 71", paragraph [0033]; outlet 107, also shown in annotated Fig. 9 below),
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Hannemann in view of Kodaira does not teach wherein the air filtration system comprises one or more intake filters configured to permit cooling air flow to enter the pathogen impermeable enclosure while preventing pathogens from entering an internal volume of the pathogen impermeable enclosure.
However, McMahon teaches an isolation enclosure (paragraph [0006]; module 10, Fig. 1-3, air intake 50, air outtake 52, Fig. 5) for patients that includes an air filtration system wherein the air filtration system comprises one or more intake filters (“high-efficiency particulate air filter machine is on an air outtake”, claim 4) configured to permit the cooling air flow to enter (“air conditioning system comprising an air intake…the air outtake ensures that the air circulating within the module”, paragraph [0038]) the pathogen impermeable enclosure while preventing pathogens and/or vaporized sterilization solutions from entering an internal volume of the pathogen impermeable enclosure (“hepa filter to capture contagions”, paragraph [0039]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the pathogen impermeable enclosure of Hannemann with the inlet and outlet system of Kodaira in order to provide an imaging system enclosure that supplies cooling air to an interior of the pathogen impermeable enclosure and exhausts air in order to provide cooling airflow to circulate within the enclosure and keep the device components cooled, while further combining it with the one or more intake filters of McMahon to also prevent the passage of pathogens, airborne particles, and unwanted vaporized sterilization solutions from entering the internal volume of the pathogen impermeable enclosure.
Regarding claim 3, Hannemann in view of Kodaira and further in view of McMahon teaches all the limitations of claim 1.
Furthermore, Kodaira teaches the pathogen impermeable enclosure that comprising a gantry enclosure assembly ("the gantry fixing unit 60 are covered by a cover 70", paragraph [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the modified imaging system isolation enclosure with Kodaira in order to cover the gantry, providing a barrier between the patient and the imaging system, and cooling the interior of the gantry.
Regarding claims 11 and 12, Hannemann in view of Kodaira and further in view of McMahon teaches all the limitations of claim 1.
Furthermore, Kodaira teaches the air filtration system including a first conduit in fluid communication with a clean air source coupled to the inlet ("a lower cover 111 is provided with an inlet 113 for sucking air into the gantry", paragraph [0004]; shown in annotated Fig. 10 below) of the pathogen impermeable enclosure and a second conduit in fluid communication with a clean air source coupled to the outlet ("outlet 119 is provided to exhaust air", paragraph [0005]; shown in annotated Fig. 10 below) of the pathogen impermeable enclosure.
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the modified imaging system isolation enclosure with Kodaira to implement a first conduit to intake clean air and a second conduit to exhaust air to help with the passage of air flow into the inlet of the pathogen impermeable enclosure and to the interior of the imaging system for cooling.
Regarding claim 13, Hannemann in view of Kodaira and further in view of McMahon teaches all the limitations of claim 12. Hannemann teaches conduits for air flow sealingly coupled into the pathogen impermeable enclosure ("external connecting lines integrated in the film", paragraph [0026]; connecting lines 15, film 7, Fig. 1, Fig. 2, Fig. 4).
Furthermore, Kodaira teaches the first and second conduits sealingly coupled to the enclosure for air flow into the imaging system ("air entering the gantry 10 flows in a plurality of flow paths constructed in the gantry 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the modified imaging system isolation enclosure to sealingly couple the first and second conduits into the pathogen impermeable enclosure to provide cooling within the interior of the imaging system while providing a barrier between the patient and the imaging system.
Regarding claim 14, Hannemann in view of Kodaira and further in view of McMahon teaches the first and second conduits coupled to the jacket ("external connecting lines integrated in the film", paragraph [0026]; Fig. 1, Fig. 2, Fig. 4; Hannemann) via chemical welding, heat welding, or use of rubber zipper to facilitate a pathogen impermeable seal therebetween. The connecting lines of Hannemann are integrated into the film which are the suitable means to be sealed to the jacket, such as heat welding.
Regarding claim 15, Hannemann in view of Kodaira and further in view of McMahon teaches the first and second conduits being formed of a pathogen impermeable material. Since the first and second conduits are integrated (paragraph [0026]; connecting lines 15, Fig. 1, Fig. 2; Hannemann) into the sterile film or pathogen impermeable film (paragraph [0002]; film 7, Fig. 1, Fig. 2; Hannemann), it should already be pathogen impermeable.
Regarding claim 16, Hannemann in view of Kodaira and further in view of McMahon teaches all the limitations of claim 1.
Furthermore, McMahon teaches an isolation enclosure (paragraph [0006]; module 10, Fig. 1-3, air intake 50, air outtake 52, Fig. 5) for patients that includes an air filtration system with air vents that have filters (paragraph [0039]; vents 54 & 56, Fig. 6).
Although the isolation enclosure taught in McMahon is not designed for an imaging system, it would have still been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the modified imaging system isolation enclosure with the filters of McMahon, as both have an air filtration system and both filters are claimed to have air flow in and out, and to protect the patient from spreadable pathogens as well as known to prevent contaminants into different parts of the system.
Claims 2 and 4-10 are rejected under 35 U.S.C. 103 as being obvious over Hannemann in view of Kodaira and further in view of McMahon and furthest in view of Braun (EP 1262146 B1).
Regarding claim 2, a modified imaging system isolation enclosure teaches all the limitations of claim 1. Hannemann teaches the pathogen impermeable enclosure comprising a flexible jacket ("elastically deformable, e.g. stretchable film", paragraph [0014]; film 7, Fig. 1-4), but does not teach a plurality of conical components sealingly coupled to the jacket and a cylindrical bore tube.
However, Braun teaches a plurality of conical components ("funnel shaped openings", paragraphs [0012], [0014]; side sections 24, Fig. 2) and a cylindrical bore tube ("tube which is opened on both sides in the tunnel-shaped device" [0012], "cylindrical middle part" [0014]; cylindrical center section 22, Fig. 2) sealingly coupled to the plurality of conical components (shown in annotated Fig. 2 below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the modified pathogen impermeable enclosure by coupling the conical components and cylindrical bore tube of Braun to the jacket, as both are covers to fit around the imaging system. The enclosure taught by Hannemann in view of Kodaira and further in view of McMahon also goes through the opening, however combining it with the conical components of Braun would make a more structured fit for the bore of the gantry, ensuring a proper barrier and entry point between the patient and the machine.
Regarding claim 4, the modified imaging system isolation enclosure in view of Braun teaches the all the limitations of claim 2, as well as the jacket, the conical components, and the openings.
The combined teaches of the film coupled to the systems would teach that each attachment point constitutes an opening for attaching the film to the system as Hannemann teaches the film being sealed to multiple points of the opening portion of the system (film 7, grooves 8, patient receiving opening 3, Fig. 2) and Braun further teaches an elastic means coupled directly to the conical sections (elastic means 26, Fig. 2).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to reasonably modify the modified enclosure with the conical components of Braun with the same method of coupling to create one whole enclosure or jacket for the imaging system as both covers are meant to provide a barrier between the patient and the device, as well as protect the enclosed space from contaminants or spreadable pathogens.
Regarding claim 5, the modified imaging system isolation enclosure teaches the limitations of claim 4, but does not teach the coupling methods of the conical components to the openings in the jacket. Grooves are taught in Hannemann, where the film is secured to pass through the bore of the imaging system (paragraph [0032], "grooves 8 can be formed within the patient receiving opening 3" [0045]; Fig. 1, Fig. 2) and mentions "rubber bands, plastic, textile, or metal bands" as holding means for the film (see paragraph [0035]).
However, Braun teaches the use of elastic hoops/straps to fasten both ends of the conical components onto the openings of the enclosure (paragraph [0017], [0020], [0025]; elastic means 26, Fig. 2) to fit accordingly and create an airtight seal.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the jacket of the modified imaging system isolation enclosure to incorporate the conical components of Braun with the use of the disclosed holding means such as the elastic hoops to create an airtight seal within the bore.
Regarding claim 6, the modified imaging system isolation enclosure teaches all the limitations of claim 2, but does not teach the bore tube or the conical components needed to be coupled to the bore tube. Hannemann does teach the utilization of tape ("the film is loosely placed on the medical device with an adhesive tape", paragraph [0002]).
Braun teaches a bore tube ("tube which is opened on both sides in the tunnel-shaped device" [0012], "cylindrical middle part" [0014]; cylindrical center section 22, Fig.2) wherein the conical components are clamped and fastened together ("outwardly widening sections form funnel-shaped openings...optionally..can be easily inserted", paragraph [0014]; sides sections 24, Fig. 2) using elastic hoops/straps (paragraph [0017], [0020], [0025]; elastic means 26, Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified imaging system isolation enclosure with the bore tube of Braun in order to ensure an airtight seal for the enclosure around the bore of the gantry of the imaging system.
Regarding claim 7 and 9, the modified imaging system isolation enclosure teaches the jacket and the imaging system isolation enclosure of claim 2, but does not teach the material of the jacket.
However, Braun teaches the material of the cover on the conical components, being formed from polyethylene (paragraph [0016]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the jacket of the modified imaging system isolation enclosure with the material of Braun, ensuring the jacket and the conical components are both made from polyethylene, which has a high level of biocompatibility, non-toxic nature, and flexibility, which is deal for the flexible, pathogen- impermeable jacket of the imaging system.
Regarding claim 8 and 10, the modified imaging system isolation enclosure and Braun teaches all the limitations of claim 2, but do not disclose the thickness of the conical components or the jacket being between 10 mil and 50 mil thick. The examiner notes that Applicant does not present any criticality for the claimed ranges.
However, Hanneman discloses that "air cannot permeate through the film" (paragraph [0009]) and the film is stretchable (paragraph [0014]).
Braun also discloses that cover for the conical components is elasticized (paragraphs [0017], [0020]).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to reasonably modify the elasticity and durability of the modified imaging system isolation enclosure and Braun with the claimed range of between 10 mil and 50 mil thick to achieve the most optimal thickness to be stretchable and durable for the imaging system isolation enclosure as a matter of routine optimization since it has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," in re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
One of ordinary skill in the art would recognize that enclosures and jackets would provide the ideal durability and elasticity would fall in between 10 mil and 50 mil thickness.
Claim 17-19 are rejected under 35 U.S.C. 103 as being obvious over Hannemann in view of Kodaira and further in view of McMahon and furthest in view of Gromala et al. (US 20160008757 A1) (hereon referred as Gromala).
Regarding claim 17, a modified imaging system isolation enclosure teaches all the limitations of claim 1, but does not teach the air filtration system with a closed loop air handling system.
However, Gromala teaches an air filtration system including a closed loop air handling system ("closed loop configuration" [0010], "air handling system" [0072], closed loop air handling system, Fig. 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified imaging system isolation enclosure with the closed loop air handling system of Gromala as the air filtration system of Gromala is also for the filtration of contaminants and other airborne particles including pathogens in an enclosed environment such as patient rooms including an imaging system.
Regarding claim 18 and 19, a modified imaging system isolation enclosure in view of Gromala teaches all the limitations of claim 17.
Furthermore, McMahon teaches an air conditioning unit (paragraph [0013]; air intake 50, air outtake 52, Fig. 5) sealingly coupled to the pathogen impermeable enclosure via a conduit ("air intake is connected to the air outtake through the insertion portal", paragraph [0038]; air intake 50, air outtake 52, Fig. 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the modified imaging system isolation enclosure in view of Gromala with the air conditioning unit of McMahon as both air conditioning units have an air intake and outtake, helping to circulate air and ensure that the temperature in the enclosed space is regulated, for example the imaging system being cooled at its ideal temperature in order to prevent distortion of imaging results.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In regards to claim 1, Applicant argues that although McMahon describes a filter, it is not an intake filter configured to permit the cooling air flow to enter the pathogen impermeable enclosure that prevents pathogens and/or vaporized sterilization solutions from entering an internal volume of the enclosure. However, the Examiner respectfully disagrees and the argument is not persuasive. McMahon teaches the air filter being on an air outtake (item 52) which outtakes air into the system thus making it an intake filter. Vents 54 and 56 are vents such that the cooling air from air outtake 52 flows across the patient (see Fig. 6 of McMahon). Therefore, Hannemann in view of Kodaira and further in view of McMahon does teach all the limitations of claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARA LINH TRAN whose telephone number is (571)272-3598. The examiner can normally be reached 7:30am-5:00pm M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at 5712724233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.L.T./Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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