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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation is: “closed by means of a cover” in line 2 of claim 1.
Because this claim limitation is not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-11, 13-17, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McDonald (WO 9621615 A2).
Regarding claim 1, McDonald teaches An arrangement for the contamination-free introduction of a sterile object from a vessel, which has been closed by means of a cover, into a working chamber, which is surrounded by a wall, of a containment comprising:
a) a portal unit having:
aa) an access flange which is arranged in the wall and which forms a passage from the outside into the working chamber (Fig. 1: docking assembly 23 and ring seal 27 constitute a flange); and
ab) a door which sealingly closes the passage and which, in order to be opened, can be moved into the working chamber (Fig. 4a-5: door 221 on hinge 222); and
b) a vessel receptacle (Fig. 1: container 1) having:
ba) a repository for holding a vessel that has been introduced into the vessel receptacle (Fig. 1: body of container 1 formed partially by operable base 3);
bb) an opening for the introduction of the vessel into the repository (Fig. 2: opening of mouth 202 that is covered by peelable foil closure 204); and
bc) a flange for interacting with the access flange (Fig. 2: mouth 202), wherein
c) a decontamination unit is designed to, when the door has been closed, the vessel receptacle has been docked to the access flange and the vessel has been stored in the vessel receptacle, decontaminate an outer surface, facing toward the door, of the cover (Fig. 4a-5: UV lamps 226).
Regarding claim 2, McDonald teaches the arrangement as claimed in claim 1, as set forth above, and teaches wherein:
a) the door, in a closed position, is attached in a sealed manner to the access flange from the side of the working chamber, and the access flange borders an intermediate space which is situated in the passage (Fig. 1); and
b) the cover of the vessel which has been placed in the vessel receptacle is sealed between the flange and the access flange when the vessel receptacle has been pivoted into abutment against the access flange (Fig. 3: cover 241 would be between the mouth of the container 201 and the docking assembly 23; NOTE: the vessel is not positively recited in claim 1 and thus the prior art does not need explicitly recite a vessel with this particular arrangement, but merely be capable of being used with a vessel with this particular arrangement; in this case, if the vessel is tall enough to reach closure 204, the cover 241 can be interpreted to be cover of the vessel; in addition, the container 201 can be pivoted into the transfer port by screwing it in, thus pivoting around a vertical axis, or alternatively, pivoting a finite amount if the container isn’t inserted straight in).
Regarding claim 3, McDonald teaches the arrangement as claimed in claim 2, as set forth above, and teaches wherein the decontamination unit is furthermore utilizable for decontamination of the outwardly facing surface of the door (Fig. 8b: diffuser 293 would be sterilized by the UV light since it is made of transparent quartz), of the intermediate space and of that surface of the access flange which faces toward the intermediate space (Fig. 1; A ring seal 27 is provided in the docking assembly 23 at the position in an opening of wall W to prevent contamination occurring at this point. To prevent this seal constituting a possible source of contamination, the UV lamps 26 are arranged so as to irradiate the externally facing surfaces of the seal 27).
Regarding claim 4, McDonald teaches the arrangement as claimed in claim 2, as set forth above, and teaches wherein the decontamination unit, with a direction of action into the passage, is installed directly on the door (Fig. 1: UV lamps 26).
Regarding claim 5, McDonald teaches the arrangement as claimed in claim 2, as set forth above, and teaches wherein the decontamination unit, with a direction of action into the passage, is installed laterally with respect to the portal unit which has the door and the access flange (Fig. 1: UV lamps 26 are installed on a side of the door and access flange and therefore is interpreted to be installed laterally with respect to the portal unit).
Regarding claim 6, McDonald teaches the arrangement as claimed in claim 2, as set forth above, and teaches wherein the access flange has a first seal (Fig. 1: ring seal 27).
Regarding claim 7, McDonald teaches the arrangement as claimed in claim 2, as set forth above, and teaches wherein the door is equipped with a second seal which is sealed against the access flange in the closed position (Fig. 1: bottom surface of door 21).
Regarding claim 8, McDonald teaches the arrangement as claimed in claim 2, as set forth above, and teaches comprising a common seal arranged on the access flange and said common seal encompasses the access flange at its inner surfaces facing toward the intermediate space (Fig. 10: locking seal 250).
Regarding claim 9, McDonald teaches the arrangement as claimed in claim 2, as set forth above, and teaches wherein a transfer apparatus which is equipped, in the working chamber, with a tool head is designed to, when the door has been opened, the vessel receptacle has been docked to the access flange and the vessel has been stored in the vessel receptacle:
a) detach a decontaminated part of the cover from the vessel and move it into the working chamber;
and
b) move the object resting in the vessel situated in the vessel receptacle from said vessel into the working chamber (NOTE: the transfer apparatus is not positively recited and McDonald would be capable of being used with the recited transfer apparatus and therefore reads on this claim limitation).
Regarding claim 10, McDonald teaches the arrangement as claimed in claim 1, as set forth above, and teaches wherein the decontamination unit, with a direction of action into the passage, is installed directly on the door (Fig. 1: UV lamps 26).
Regarding claim 11, McDonald teaches the arrangement as claimed in claim 1, as set forth above, and teaches wherein the decontamination unit is a radiation source (Fig. 1: UV lamps 26).
Regarding claim 13, McDonald teaches the arrangement as claimed in claim 1, as set forth above, and teaches wherein a transfer apparatus which is equipped, in the working chamber, with a tool head is designed to, when the door has been opened, the vessel receptacle has been docked to the access flange and the vessel has been stored in the vessel receptacle:
a) detach a decontaminated part of the cover from the vessel and move it into the working chamber;
and
b) move the object resting in the vessel situated in the vessel receptacle from said vessel into the working chamber (NOTE: the transfer apparatus is not positively recited and McDonald would be capable of being used with the recited transfer apparatus and therefore reads on this claim limitation).
Regarding claim 14, McDonald teaches the arrangement as claimed in claim 2, as set forth above, and teaches wherein the transfer apparatus is equipped with a cutting tool for cutting-open the cover (NOTE: the transfer apparatus is not positively recited and McDonald would be capable of being used with the recited transfer apparatus and therefore reads on this claim limitation).
Regarding claim 15, McDonald teaches the arrangement as claimed in claim 2, as set forth above, and teaches wherein the transfer apparatus is equipped with a gripping tool for gripping the detached decontaminated part of the cover (NOTE: the transfer apparatus is not positively recited and McDonald would be capable of being used with the recited transfer apparatus and therefore reads on this claim limitation).
Regarding claim 16, McDonald teaches the arrangement as claimed in claim 1, as set forth above, and teaches wherein: a) the vessel has the form of a trough-shaped tub; and b) the object has the form of a nest with a raster of depression-like receiving contours for the storage of containers (NOTE: neither the vessel nor the object were positively recited in claim 1 and therefore, so long as the prior art is capable of being used with the claimed vessel and object shapes, it would read on the instant limitations; McDonald is capable of housing a vessel and object of these particular shapes).
Regarding claim 17, McDonald teaches the arrangement as claimed in claim 1, as set forth above, and teaches wherein:
a) the arrangement is assigned an input station with an air stream flowing through a filter, which stream is intended for releasing the vessels from packages provided with at least an enclosure and for providing the vessels, under controlled clean-room conditions, before these are placed into the vessel receptacle (NOTE: this is a recitation of intended use since the input station is not positively recited and merely assigned; the apparatus of McDonald can be assigned to an input station via verbal or written instructions and therefore would read on this limitation); and
b) the cover which closes the vessel maintains the sterile state of the object, situated in the interior space of the vessel, with the containers (pg. 10 lines 27-28: A peelable foil closure 204 is sealed over the mouth 202; NOTE: the closure is sealed over the mouth and therefore is capable of maintaining the sterility of the objects in the container).
Regarding claim 19, McDonald teaches the arrangement as claimed in claim 1, as set forth above, and teaches wherein the decontamination unit, with a direction of action into the passage, is installed laterally with respect to the portal unit which has the door and the access flange (Fig. 1: UV lamps 26 are installed on a side of the door and access flange and therefore is interpreted to be installed laterally with respect to the portal unit).
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over McDonald in view of Gil (US 20160101202 A1).
Regarding claim 12, McDonald teaches the arrangement as claimed in claim 2, as set forth above, but does not teach wherein the radiation source is UVC.
McDonald teaches UV lamps (Fig. 1: UV lamps 26) but does not teach a wavelength range emitted by the UV lamps. Gil teaches a UV decontamination container (abstract: An object sterilization system includes an enclosure having an access door with at least one ultraviolet emitting device supported within the enclosure. The ultraviolet emitting device(s) are for directing ultraviolet radiation on an object placed within the enclosure). Gil teaches wherein UV light in the range from 240 to 280 nm is particularly effective for sterilization (par. 36: UVA from 400 nm to 320 nm, UVB from 230 nm to 280 nm, and UVC from 280 nm to 100 nm. For germicidal applications, typically UVB radiation in the range of 280 nm to 240 nm has been shown to be most effective).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the UV lamps of McDonald to emit UVC light in the range of 240-280 nm, as taught by Gil, in order to emit light at a range that is most effective for killing pathogens.
Claims 18 is rejected under 35 U.S.C. 103 as being unpatentable over McDonald.
Regarding claim 18, McDonald teaches the arrangement as claimed in claim 17, as set forth above, and teaches wherein the cover which closes the vessel is sealed against a vessel edge of the vessel (NOTE: this is a recitation of intended use, as the vessel could be tall enough such that it is sealed by the closure 204 ) but does not teach wherein the cover which closes the vessel is semipermeable.
McDonald teaches wherein the whole container can be composed of a semipermeable material that is permeable to steam but impermeable to contaminants (pg. 7 lines 21-27: The container 1 , which is composed of heat resistant plastics material is provided with a panel 11 of a porous material which is permeable to steam but impermeable to contaminants such as bacteria or other particulates… Provided that the porous material is of sufficient strength, the whole container may be fabricated from the porous material) but does not teach wherein the closure 204 is formed of this material. However, forming the closure 204 with this material would increase the amount of steam that enters to sterilize the contents, which may increase sterilization effectiveness and efficiency during autoclaving.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the closure 204 of McDonald to be made of a porous material that is impermeable to contaminants but permeable to steam, as taught by McDonald, in order to allow more steam to enter during autoclaving and thus increase sterilization effectiveness and efficiency.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over McDonald in view of Bergin (WO 02080990 A1).
Regarding claim 20, McDonald teaches the arrangement as claimed in claim 1, as set forth above, but does not teach wherein the decontamination unit is a fumigation device.
Bergin teaches a similar sterilization transfer port apparatus (abstract: An apparatus for sterile transfer of an article between a sterile container (11) and a sterile enclosure (23); Fig. 1-2). Bergin teaches wherein the transfer port is connected to pipes for delivering gas sterilants (abstract: whereby said connection results in formation of a chamber (31) defined, at least in part, by said interconnection means and said first and second closures, said chamber being provided with means (27) for entry of fluid thereto such that the chamber can be sterilised using a suitable fluid medium; pg. 10 lines 7-12: Sterilisation of the chamber may be achieved by generating and feeding into said chamber via the means of entry of fluid thereto sterilization media, either alone or in combination, selected from sterilising vapours, liquids or gases including hydrogen peroxide, steam, ethylene oxide, formalin, peracetic acid, isopropyl alcohol or any known phenolic or chlorinated disinfectant). Adding a means of sterilization to the device of McDonald would increase the sterilization effectiveness.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the docking assembly of McDonald to be connected to pipes that deliver sterilant gas from a generator into the UV chamber 24, as taught by Bergin, in order to increase the sterilization effectiveness and thoroughness.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANGRU CHEN whose telephone number is (571)272-1201. The examiner can normally be reached Monday-Friday 7:30-5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached on (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.C./Examiner, Art Unit 1796
/KEVIN JOYNER/Primary Examiner, Art Unit 1799
Prosecution Insights