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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/01/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 8-10 and 12 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.
As to claim 8, applicant recites “the temperature sensor” which is lack of proper antecedent basis. Claim 1 never mention anything about “a temperature sensor”. The first time “a temperature sensor” being mention are in claim 7. For the purpose of examination, examiner presumes that claim 8 is depended on claim 7 instead of claim 1. Correction is required.
As to claim 9, applicant recites “the proximity sensor” which is lack of proper antecedent basis. Claim 1 never mention anything about “a proximity sensor”. The first time “a proximity sensor” being mention are in claim 7. For the purpose of examination, examiner presumes that claim 8 is depended on claim 7 instead of claim 1. Correction is required.
As to claim 10, applicant recites “the motion sensor” which is lack of proper antecedent basis. Claim 1 never mention anything about “a motion sensor”. The first time “a motion sensor” being mention are in claim 7. For the purpose of examination, examiner presumes that claim 8 is depended on claim 7 instead of claim 1. Correction is required.
As to claim 12, applicant recites “the processor” which is lack of proper antecedent basis. Claim 1 never mention anything about “a processor”. The first time “a motion sensor” being mention are in claim 7. For the purpose of examination, examiner presumes that claim 8 is depended on claim 7 instead of claim 1. Correction is required.
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.
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.
Claims 1, 3, 5 are rejected under 35 U.S.C. 103 as being unpatentable over Fuchs (2008/0141700) in view of Bernardin et al (4,884,684).
As to claim 1, Fuchs discloses a kit (10) comprising a casing (102) having a first portion (16) and a second portion (14), wherein when the kit is in an enclosed state, the first portion and the second portion define a closed space therebetween (Figure 1 and 5), a mattress (50 and 70) having at least a first part (50) and a second part (70), wherein the first part and the second part of the mattress are accommodated in the first portion and the second portion of the casing (as shown in Figure 5, 50 is place inside second portion 14 and 70 is inside first portion 16), respectively, wherein when the kit is in use, the mattress holds a refrigerant therein *[0021] teaches a plurality of refrigerant filled cubes 52, 72), a temperature of the refrigerant lies within a predefined range of temperature, and wherein the mattress is deformable such that its deformability depends on the temperature of the refrigerant (distilled water or brine solution being the refrigerant, as the distill water and brine water solidified due to temperature, the phrase change from water to slush to solid, therefore, the mattress is deformable as the phase change), at least one storage panel (60) having a plurality of straps (64, 66) and pocket 62) in order to hold medicine and medical accessories ([0022]), wherein when the kit is in the enclosed state, the at least one storage panel (60) is encased by the first part and the second part, thereby enabling a temperature of the samples held in the plurality of containers to be maintained within the predefined range of temperature (Figure 5, [0025] teaches that the refrigerant to continuously main the medicines in the refrigerated state).
However, Fuchs does not disclose at least one stencil having a plurality of openings of a first type, wherein the plurality of openings of the first type are dimensioned to receive a plurality of containers therein and to hold the plurality of containers securely, each container being capable of holding a sample therein and being closed at its first end.
Bernardin discloses a container for holding biological material comprises a casing (10) with a first portion (28A) and a second portion (28B), wherein when the kit is in an enclosed state, the first portion and the second portion define a closed space therebetween (Figures 4-7), the casing further comprises at least one stencil (40A-C) having a plurality of openings of a first type (16A-H, first type being 16A and 16E, second type being 16B and 16F…etc), wherein the plurality of openings of the first type are dimensioned to receive a plurality of containers (16A and 12E) therein and to hold the plurality of containers securely, each container being capable of holding a sample therein and being closed at its first end (biological sample or hazardous material).
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 panel of Fuchs with stencil like holder with opening that is open that through the material as taught by Bernardin in order to successfully refrigerate the inner biological sample from both the top and bottom equally via the opening from both the top and bottom of the stencil.
As to claim 3, Fuchs as modified further discloses at least one plate (56 or 94) arranged between a given portion of the casing (34) and a corresponding part of the mattress (50), wherein the at least one plate is capable of holding at least one of: the refrigerant a sample held in a given container, upon leakage thereof (upon leaking, the leak refrigerant can be held inside the back and the flap of the material).
As to claim 5, Fuchs as modified further discloses a lock (zipper), wherein when the kit is in use, the lock is operable to open and to securely close the first portion and the second portion with respect to each other, for attaining an open state and the enclosed state of the kit, respectively ([0020]).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Fuchs (2008/0141700) in view of Bernardin et al (4,884,684), further in view of Nemard (9,072,653).
As to claim 2, Fuchs as modified does not disclose a plurality of holders for the plurality of containers , wherein a given holder is arranged on a second end of a corresponding container to facilitate detachment or attachment of said container in a corresponding opening of the first type, and wherein said opening of the first type is dimensioned to receive an arrangement of the given holder with its corresponding container therein and to hold said arrangement securely. Nevertheless, Nemard discloses a medication support case (20) with foam insert (40 and 41), the plurality of foam insert further comprises a plurality of opening, and a plurality of holders (45) for the plurality of containers , wherein a given holder is arranged on a second end of a corresponding container to facilitate detachment or attachment of said container in a corresponding opening of the first type, and wherein said opening of the first type is dimensioned to receive an arrangement of the given holder with its corresponding container therein and to hold said arrangement securely (securement strap 45 to secure each medical articles within the depression). 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 stencil of Fuchs with plurality of holders as taught by Nemard in order to provide additional security to the article store within the stencil.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Fuchs (2008/0141700) in view of Bernardin et al (4,884,684), further in view of Wingate, III et al (10,842,712).
As to claim 6, Fuchs as modified does not disclose visual indicators indicative of a correct manner of positioning the plurality of containers in the plurality of openings of the first type are provided on at least one of: the at least one stencil, the mattress, the plurality of containers.
Nevertheless, Wingate discloses a medicine portfolio and organizer (100), the organizer comprises plurality of holders (212, 234, 240, 236) to hold plurality of medication, calendar, pad, medicine pad etc. Each of the holders comprises labels (316) can be placed into or onto the label holder (312) to identify the product within containers. 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 stencil of Fuchs as modified with identification as taught by Wingate in order to provide identification to the content within the container for the use of the medication.
Claims 7-12 are rejected under 35 U.S.C. 103 as being unpatentable over Fuchs (2008/0141700) in view of Bernardin et al (4,884,684), further in view of Olson et al (20080111685).
As to claims 7-12, Fuchs as modified further discloses the at least one stencil further comprises at least one opening of a second type for holding a second type of container, does not disclose at least one sensor therein, the at least one sensor being implemented as at least one of: a temperature sensor, a motion sensor, a proximity sensor, wherein the temperature sensor, in operation, generates sensor data indicative of a temperature in the closed space between the first portion and the second portion of the casing, the temperature sensor being communicably coupled to a processor, and wherein the processor is configured to determine whether the temperature in the closed space lies outside the predefined range of temperature, and generate an indication indicative of an anomalous temperature condition when it is determined that the temperature in the closed space lies outside the predefined range of temperature,
the proximity sensor, in operation, generates sensor data indicative of distances of the plurality of containers from the proximity sensor, the proximity sensor being communicably coupled to a processor, and wherein the processor is configured to determine whether a given container is removed from its corresponding opening of the first type, based on the sensor data and pre-known distances of the proximity sensor from the plurality of openings of the first type, and generate at least an indication indicative of removal of the given container from its corresponding opening of the first type, when it is determined that the given container is removed from its corresponding opening of the first type, the motion sensor, in operation, generates sensor data indicative of motion of the kit, the motion sensor being communicably coupled to a processor, and wherein the processor is configured to determine whether the motion of the kit exceeds a predefined threshold value, and generate an indication indicative of an anomalous motion condition when it is determined that the motion of the kit exceeds the predefined threshold value, the kit further comprises the processor, the kit further comprises at least one indicator arranged on at least one of: the casing, the at least one stencil, the at least one indicator being coupled to the processor, and wherein the at least one indicator is at least one of: a light-emitting element, a sound-emitting element, a haptic element.
Olson discloses a container (200) comprises a container and packaging material for medical and pharmaceutical products ([0034]), the container (Figure 2 ) comprises at least one sensor (224, 225) therein, the at least one sensor being implemented as at least one of: a temperature sensor, a motion sensor, a proximity sensor ([0045]) teaches that sensor 224, 225 can be motion sensors, temperature sensors), wherein the temperature sensor, in operation, generates sensor data indicative of a temperature that is outside a predetermined range, the temperature sensor being communicably coupled to a processor (222), and wherein the processor is configured to determine whether the temperature in the closed space lies outside the predefined range of temperature, and generate an indication indicative (verbal/sound warning) of an anomalous temperature condition when it is determined that the temperature in the closed space lies outside the predefined range of temperature ([0039]) , the proximity sensor ([0039] and [0044] teaches that that sensor can be proximity sensor), in operation, generates sensor data indicative of distances to detect the presence of an object within the predetermined distance of the sensor ([0045]), the proximity sensor being communicably coupled to a processor (222), and wherein the processor is configured to determine whether the presence of an object within the predetermined distance of the sensor and generate at least an indication indicative (verbal/sound warning ), the motion sensor ([0041 and 0079] teaches the motion sensor), in operation, generates sensor data indicative of motion of the kit, the motion sensor being communicably coupled to a processor (222), and wherein the processor is configured to determine whether the motion of the kit exceeds a predefined threshold value ([0079] teaches the motion sensor to detect when the device is being used above a predetermined speed), and generate an indication indicative (verbal/sound warning) of an anomalous motion condition when it is determined that the motion of the kit exceeds the predefined threshold value, the kit further comprises the processor (222), the kit further comprises at least one indicator (228) arranged on at least one of: the casing (Figure 2 shows that the indicator is on the surface of the container), the at least one indicator being coupled to the processor (Figure 2), and wherein the at least one indicator is a sound-emitting element (speaker).
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 container of Fuchs with verbal/sound warning system with sensors, processor and indicator coupled to the kit as taught by Olson in order to provide an warning system to warn the user whether the temperature is raise above threshold value, motion that exceeds predefined threshold or items not in range of the proximity of the sensor so the user can response to the situation quickly prior the medication inside diminished or the medication may even change sufficiently so as to pose a health risk.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Fuchs (2008/0141700) in view of Bernardin et al (4,884,684), further in view of Blezard et al (9,267,722).
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As to claims 13-14, Fuchs as modified does not specifically disclose the mattress has a spout or opening that is resealable, and wherein the refrigerant is filled into the mattress and/or discharged out of the mattress, via the spout and the first part and the second part of the mattress are fluidically connected to each other via at least one bridge part of the mattress, and wherein when the kit is in use, the at least one bridge part holds the refrigerant therein. Nevertheless Blezard discloses a phase change material bladder comprises a filling spout ( 24) and the phase change material bladder is in the shape of a cross with multiple parts (Figure 1) in order to protect at least five side of the container (Figure 5) and each of the parts of the bladder are connected via bridge part (as annotate above). 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 mattress of Fuchs with removable cooling mean with spout and the part are connect with each other as taught by Blezard in order to refill the refrigerant and dispose the refrigerant within the mattress and have a connecting bridge between the part to ensure that the central binder portion of Fuchs with additional cooling refrigerant to ensure cooling of the medicine and medical accessories in the refrigerated state.
Allowable Subject Matter
Claims 4 and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Examiner has cited particular paragraphs and/or columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested of the applicant, in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or prior art(s) disclosed by the Examiner (in the attached PTO-892 form).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHUN HOI CHEUNG whose telephone number is (571)270-5702. The examiner can normally be reached Monday to Friday 9AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Orlando E Aviles can be reached at (571)270-5531. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHUN HOI CHEUNG/Primary Examiner, Art Unit 3736