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 .
DETAILED ACTION
Examiner’s Comments
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.
Column and line (or Paragraph Number) citations have been provided as a convenience for Applicants, but the entirety of each reference should be duly considered. Any recitation of a Figure element, e.g. “Figure 1, element T should be construed as inherently also reciting “and relevant disclosure thereto”.
Specification
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. The specification at [117] and [118] discloses a plurality of references not cited in the IDS.
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 text of those sections of Title 35, US Code not included in this action can be found in a prior Office action.
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.
Claims 1-2, 4, 10-12, 18, 26-27, 36, and 53 are rejected under 35 U.S.C. 103 as being unpatentable over WO 849 in view of KR 10-2171850 B1 (KR 850) and further in view of JP 212, or alternatively Yamamoto (2011/0265894).
For claim 1, WO 2017-194849 (WO 849) discloses a mobile diagnostic structure (1), comprising:
a housing (base station) including a space therein;
a partitioning module partitioning the space to include a preparation room (2) and an analysis room (3);
an inlet module (4a) providing an incoming path from an outside to the preparation room for a raw sample; and
a transfer module (4b) providing a transfer path from the preparation room (2) to the analysis room (3), for a pre-treated sample which is a result of pre-treating the raw sample in the preparation room.
For claim 53, the structure further includes a sample collecting room (9) partitioned from the preparation room (2).
For claim 2, the partitioning module (FIG.1) includes a barrier unit (dividing wall, FIG.1) blocking transfer of the pre-treated sample between the preparation room (2) and the analysis room (3),
wherein the pre-treated sample is transferred from the preparation room to the analysis room via the transfer module.
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For claim 4, the transfer module (4b) includes a door unit configured to open or close an opening for the transfer module, the opening being formed in the partitioning module (this feature is implicit in WO849; the module creates a closure (closure system 4b) between the two spaces (2 and 3) and there by “sealing off” the spaces from each other and “allowing samples to be transmitted” therebetween).
For claim 12, WO 849 discloses the inlet module (4a) including (see abstract; figure 1) “an alternate-opening airlock system (4a) between the outside and the pre-PCR area (2) of a suitable size for the passage of a sample, said alternate-opening airlock system (4) allowing samples to be transmitted between the outside and the pre-PCR space (2)’). This inlet module (4a) would implicitly include a door for opening/closing an opening for the inlet module, the opening for the inlet module being formed in the housing.
For claim 18, WO 849 discloses (see page 5; figure 1) “two closure systems (8), one between the outside of the mobile laboratory (1) and the pre-PCR space (2) and the other closure system between outside the mobile laboratory (1) and the post-PCR space (3)”), where the systems (8) can constitute a first entrance/exit module providing a first entrance/exit path used when a practitioner moves between the outside and the preparation room.
For claim 26, WO 849 discloses (see abstract; page 5; figure 1) “an alternate-opening airlock system (4a) between the outside and the pre-PCR area (2) of a suitable size for the passage of a sample”, “two closure systems (8), one between the outside of the mobile laboratory (1) and the pre-PCR space (2) and the other closure system between outside the mobile laboratory (1) and the post-PCR space (3)’), where the incoming path and the first entrance/exit path (8,8) do not overlap (FIG.1, see where 4a does not overlap with 8).
For claim 27, WO 849 provides a second entrance/exit module (8, FIG.1) providing a second entrance/exit path used when a practitioner transfer module moves between the outside and the analysis room.
For claim 36, the first entrance/exit module (8) is provided in the preparation room and the second entrance/exit module (8) is provided in the analysis room and the first entrance/exit module and the second entrance/exit module are disposed to contact each other with the partitioning module interposed therebetween (FIG.1).
For claim 1, WO 849 lacks the transfer module includes a middle chamber providing a predetermined space where the pre-treated sample is to be placed, a preparation room-side door unit configured to open or close a connection passage between the middle chamber and the preparation room and an analysis room-side door unit configured to open or close a connection passage between the middle chamber and the analysis room.
KR 850 teaches a safety relay device for non-face-to-face object delivery (see paragraphs [0017]-[0019]; figures 1-2: a main body (12) and first and second doors (141,142)).
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The device is provided with (see para [0017]-[0019], [0062]; figures 1-2) a main body (12), first and second doors (141,142)”; the “specimen delivery safety relay device 100 is constructed to collect a specimen in the first independent space 10 and transfer the collected specimen 50 to the second independent space 20 for collection, and in the first independent space 10”.
For claim 10, the specimen sampled in the first independent space 10 of KR 850 is in an environment in which the pressure is maintained at a lower pressure with respect to the second independent space 20 ([0049]).
KR 850 essentially provides an air lock between the two spaces so that the positive side pressure and the negative side pressure is maintained when the doors are respectively opened. Despite the disclosure that the pressure of each independent space is maintained, there is no apparent mechanism by which this occurs and no controller to allow for adjustment.
JP 2000-54212 (JP 212) provides knowledge of the prior art, specifically disclosing a box having doors facing the inside and outside of a room set to a predetermined atmosphere to allow articles to be transferred therebetween. Conventionally, pass boxes were well known where either the internal pressure is set to a positive pressure so as to prevent bacteria from entering from the outside or the internal pressure is set to a negative pressure so that microorganisms within the box do not go outside. It is known that at the time of delivery of articles between the rooms, a pressure difference would exist ([0002]). In the instance scenario, ozone gas is fed into the box body (5) via a control unit, which can adjust and control the amount of gas entering the chamber, for faster and more efficient sterilization.
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Alternatively, Yamamoto (2011/0265894) discloses an apparatus for controlling an internal pressure of a hermetically sealed chamber (pass box 4) at a specific pressure level. The disclosed pass box (4) provides an inlet passage (12) and an outlet passage (20) with chamber (4) therebetween and a controller (46) controls and adjust/maintain the internal air pressure ([0002]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and with a reasonable expectation of success to have provided the transfer module of WO 849 with a middle chamber, preparation room side door unit, and analysis room side door unit as taught by KR 850 and a control unit as taught by either JP 212, or alternatively Yamamotor, in order to allow the pressure of the preparation and analysis rooms to be adjusted and maintained when the doors are opened and to improve safety for the passage of samples, prevent bacteria, microorganisms, or other hazards.
For claim 11, WO 849 implicitly disclose a door opening/closing control unit (such as a human user) controlling at least one of the preparation room-side door unit and the analysis room-side door unit so that while either the preparation room-side connection passage or the analysis room-side connection passage becomes open, the other remains closed (figure 1: “said airlock comprising two additional closure systems, one allowing access to the pre-PCR space (2), and the other to the post-PCR space (3), these two closure systems cannot be opened together and both can only open when the closure system (8) between the outside and the airlock is closed, in order to prevent any contamination’).
WO 849 presented airlocks between spaces 2 and 3 and a system for alternately operating/opening the airlocks making the spaces 2 and 3 sealed from each other.
WO 849, as modified with KR 850, further provided for maintaining the separate spaces at distinct pressures where space 10 is maintained at a lower pressure than space 20.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over WO 849.
For claim 3, though not explicitly disclosed WO 849 anticipates the use of windows (optically transparent units) in the discussion of the lighting. Specifically, WO 849 discloses electrical networks, outlets, and generators if the structure does not comprise windows.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and with a reasonable expectation of success to have placed the disclosed windows of WO 849 at the partition module as a design choice for enhancing visibility and communication/information between rooms.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over WO 849 in view of KR 10-2011-0052006 A (KR 006).
For claim 5, WO 849 lacks the transfer module further includes
an air curtain blocking an air flow through the opening for the transfer module between the preparation room and the analysis room.
KR 006 teaches an air curtain for sterilization (see paragraph [0019]; claim 1; figures 3-5: “an air barrier film 100”, “a sterilization lamp 20 which is installed inside the case and irradiates light ray for sterilization’).
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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 and with a reasonable expectation of success to have provided the transfer module of WO 849 with an air curtain as taught by KR 006 in order to block airflow therethrough.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over WO 849, as modified above, and further in view of Mouzannar (2013/0025221).
For claim 7, WO 849, as modified, discloses the transfer module and middle chamber as recited but fails to provide a UV radiator configured to radiate UV light to an inside of the middle chamber.
Mouzannar teaches a tissue bank facility which reduces personnel circulation and therefore minimize air turbulence and risk of errors by passing material through special airtight double door pass-through chambers ([0027]). Pass-through chambers are between diagnostic and processing rooms, between processing rooms and storage rooms and between storage and release rooms, if the latter exists. These chambers can include a UV lamp (“UV radiator”) that can be switched on when nothing is passing through and off when the door is accessed. Windows between receiving and shipping rooms can be either single panel windows, or the double panel chambers described above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and with a reasonable expectation of success to have provided the middle chamber of the transfer module of WO 849, as modified, with a UV radiator as taught by Mouzannar in order to radiate the sample prior to handling thereby increasing safety of occupants.
Claims 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over WO 849 in view of JP 2019-027980.
For claims 37-38, WO 849 lacks a calibration notification unit and vibration detection module both features known from JP 980.
Specifically, JP 980 teaches a biological sample analyzer and provides a method (see paragraphs [0027]-[0029]; claims 2, 6; figure 7) where "at least one accelerometer 501, which is a vibration detection unit for detecting the vibration of the analyzer, is provided in the biological sample analyzer 700 or on the floor where the biological sample analyzer is installed", “an alarm unit that issues an alarm when vibration is detected by the vibration detection unit’, “The alarm unit detects vibration by the vibration detection unit and corrects the ion current detected by the detection unit’.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and with a reasonable expectation of success to have provided WO 849 with a vibration detection module and notification (alarm) unit as taught by JP 980 in order to detect and alert users when a vibration has occurred thereby keeping analysis accurate.
Claims 39-42 are rejected under 35 U.S.C. 103 as being unpatentable over WO 849 in view of KR 10-1913198 (KR198) and CN 104655430 (CN 430).
For claims 39-40, WO 849 fails to provide a suction unit as recited.
KR 198 teaches a fume hood for a laboratory (see paragraph [0014]; claim 1; figures 1-4) where "discharge means 200” are provided at the upper end of the experiment space (S) for discharging the internal air to the outside.
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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 and with a reasonable expectation of success to have provided the analysis room of WO 849 with a suction unit (discharge means) disposed vertically above a detection unit as taught by KR 198 as a safety precaution to dispel air.
For claims 41-42, WO 849, as modified with KR 198, now discloses because KR 198 teaches (paragraphs [0009], [0026]; figure 1) “a door 300 slid in the vertical direction” provided on one side of the body 100 to open and close the opening 110, “when the door is closed (downward), air is sucked in from the experimental space (S), and when the door is open (raised), it is predictable that air from the laboratory as well as the experimental space (S) is sucked in”.
Although, the additional feature of claim 41, relating to air used for cooling the detection device, is not explicitly disclosed in KR 198, CN 104655430 teaches a cooling type vibration signal sensing device which air conduit which is sleeved on cable such that cooling air flow channel is formed between air conduit and cable and air is discharged into chamber through air conduit.
It would further have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and with a reasonable expectation of success to have provided the detection device of WO 849, as modified, of the type taught by CN 430 that requires temperature control and therefore cooling air as an obvious expedient because some vibration sensors require cooling to maintain accurate and longevity depending on the specific application, device type, and environmental conditions.
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over WO 849 in view of KR 198.
WO 849 discloses (see page 12) “the mobile laboratory according to the invention comprises at least one instrument-holder (6)’”).
KR 198 teaches (see paragraph [0028]; figures 2-4) “a fluid guide part 500” that “guides external air flowing into the opening 110 and internal air of experimental space S having main body rear plate 103 or the main body side plate 102 attached to the inner wall surfaces’ where the plates constitute a “rack” as recited.
It would further have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and with a reasonable expectation of success to have provided the detection device of WO 849 with a rack (plate) as taught by KR 198 in order to guide air flow.
Claims 47-48 are rejected under 35 U.S.C. 103 as being unpatentable over WO 849.
For claims 47-48, WO 849 discloses (see claims 1, 6) “said mobile laboratory being adapted for genetic analysis and identification of an individual from a biological sample directly at the sampling site of said sample”, “it comprises a mobile additional space (11) for sampling and / or sampling storage, and / or an interpretation zone, and / or a meeting area’.
WO 849 lacks the sample collecting room (11) being provided in the preparation room (2) but it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and with a reasonable expectation of success to have altered the configuration of the space of WO 849 to allow the sample collecting room within the preparation room as an obvious design expedient based on the available dimensions and structure and since applicant has not disclosed that configuring the space in the recited manner solves any stated problem or is for any particular purpose and it appears other arrangements would perform equally well. Changing the design would not change the use of the device or produce an unexpected result.
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over WO 849 in view of CN 111593909 (CN 909).
For claim 50, WO 849 lacks the recited glove wall.
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CN 909 teaches a medical negative pressure sample sampling cabin (claim 6; figures 2-3) with "the transparent sampling window” comprising “a transparent partition window (7), a plurality of glove holes (22)” arranged on the transparent partition window (7), and each glove hole (22) in one-to-one corresponding sealing connection with a sleeve connecting glove (5) arranged inside the sampling room (1)").
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and with a reasonable expectation of success to have provided a glove wall as taught by CN 909 for use with WO 849 in order to further antiseptically contain the sample.
Response to Arguments
Applicant’s arguments with respect to claim(s) as amended 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.
For the prior art combination rejection, Applicant’s arguments are not persuasive.
Applicant argues the cited references fail to provide the air pressure controller. Examiner submits that at least JP 212 provides a controller and that the feature is not novel. Air locks are known to include controllers for modulating pressure.
Applicant goes on to argue there is no motivation to combine specifically pointing out that (Hubac) WO 849 is directed to a mobile lab with air lock system while KR 850 (Song) is directed to a relay device and each reference has different objectives and scope. This argument appears to be one of non-analogous art and not one of lack of motivation to combine. Examiner notes the references are analogous art in that they are both in the same field of endeavor in that both are related to contamination risks and/or are reasonably pertinent to the particular problem with which the inventor was concerned, that of contamination/preventing infection.
Finally, applicant argues there is no reasonable expectation of success but provides not rationale or reasoning to support the argument. As such, the rejection, as modified above based on claim amendments, is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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 HILARY L GUTMAN whose telephone number is 571.272.6662. 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, PAUL DICKSON can be reached on 571.272.7742. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the 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. Should you have questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HILARY L GUTMAN/Primary Examiner, Art Unit 3614