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 11/21/2024 was filed after the mailing date of the application on 7/11/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
On pg. 6, line 23, “especially usefully base” should read “especially useful base.”
Appropriate correction is required.
Examiner Note
Examiner Note: Claim 1, line 9, recites “a passage opening.” Examiner has reviewed the Drawings and Specification but cannot find any element number nor explicit explanation of where this passage opening is. It’s the Examiner’s position that the passage opening is located around the outer edge of the measuring sensor sleeve (8) base as shown in Figure 2.
Claim 1, line 12, recites “an entrance opening.” Examiner has reviewed the Drawings and Specification but cannot find any element number nor explicit explanation of where this entrance opening is. It’s the Examiner’s position that the entrance opening is the surrounding area of the sensor sleeve (8) base, on the bottom side (not shown) of the tray as shown in Figure 2.
If Examiner has misconstrued this interpretation, please clarify in the next reply. See the diagram below for the Examiner’s interpretation of the passage opening and the entrance opening.
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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 1-11 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.
Regarding Claim 1, the limitation “the adjoining material” has a lack of antecedent basis in Claim 1. Moreover, it’s unclear what “the adjoining material” is derived from. For example, is the adjoining material a separate thing from the measuring sensor sleeve? Or is it the material of, or the measuring sensor sleeve itself? It’s noted that the measuring sensor sleeve already recites “a connecting edge.”
Examiner has consulted with the Applicant’s specification for clarity, but the specification doesn’t specify what the “the adjoining material” clearly is.
For the purpose of examination, Examiner will consider the “the adjoining material” to be a part of the measuring sensor sleeve.
To overcome this rejection, “the adjoining material” should be amended to read “an adjoining material,” with an explanation of what the adjoining material is relative to the other claimed structural components in claim 1.
Claims 2-11 are also rejected by virtue of their dependency on Claim 1.
Regarding claim 2, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase “preferably,” i.e. “in a cruciform shape,” are part of the claimed invention. See MPEP § 2173.05(d).
For the purpose of examination, the claimed transverse bar as recited in claim 2 will be examined as not necessarily requiring a cruciform shape.
To overcome this rejection, it’s suggested to positively claim the shape of the transverse bar, such as by removing the “preferably” in the claim language.
Regarding claim 9, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase “preferably,” i.e. “welded,” is part of the claimed invention. See MPEP § 2173.05(d).
For the purpose of examination, the “preferably welded” step will be examined as if not necessarily required.
To overcome this rejection, it’s suggested to positively claim this limitation and remove the “preferably” language.
Regarding Claim 2, the limitation “which for their part” in line 5 renders the claim indefinite since it’s not entirely clear what this means. Claim 2 recites, “at least one transverse bar, preferably in a cruciform shape, which for their part have a passage opening.” Is “for their part” in reference to the at least one transverse bar? Is it in reference to a cruciform feature? Or something else?
Regarding Claim 3, the limitation “assigned” renders the claim indefinite for the following reasons. Claim 3 recites, “a screw connection is assigned to the measuring sensor sleeve.” Does “assigned” require a specific structural configuration of the screw connection relative to the sensor sleeve?
The term “precisely” in claim 3 is a relative term which renders the claim indefinite. The term “precisely positioned fastening” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
For the purpose of examination, any positioned fastening will be considered “precise” positioning.
Regarding Claim 3, “a temperature sensor that can be inserted through the screw connection” renders the claim indefinite since claim 3 depends from claim 1, and claim 1 already introduces “a temperature sensor” in line 11. Therefore, it’s unclear if the temperature sensor in claim 3 is the same as that of claim 1.
They appear to be the same temperature sensor and claim 3 will be examined this way.
To overcome this rejection, “a temperature sensor” in claim 3 should be amended to read “the temperature sensor.”
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 1-5, and 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over McCarthy et al. (WO2014165222 cited in the Applicant’s IDS filed on 11/21/2024, hereinafter McCarthy) in view of Mueller et al. (US11377276 cited in the Applicant’s IDS filed on 11/21/2024, hereinafter Mueller).
Regarding Claim 1, McCarthy teaches a freeze-drying tray (device 100, Fig. 1), comprising a tray frame (frame 101, Fig. 2) having a sealable access opening (filling port 109, Fig. 2; pg. 30 lines 33-34 and pg. 31 lines 1-2) and a circumferential wall (enclosing frame wall 104, Fig. 2), which on a free edge has a first projection (first internal upper skirt rim area 119, Fig. 1), on which a filter cloth (gas permeable membrane 105, Fig. 2) is circumferentially affixed and the filter cloth is sealingly fused and pressed along its outer edge with the tray frame using heated tool welding (pg.19, lines 4-6 - “heat sealing techniques”; pg. 33, lines 11-17 – “pressure and localized heating… dielectric probe, an ultrasonic probe or other type of means of locally melting and intermeshing two molten surfaces together”).
Furthermore, it’s noted that the limitations “sealingly fused and pressed,” and “heated tool welding” constitute product-by-process limitations. Per MPEP 2113, PRODUCT-BY-PROCESS CLAIMS ARE NOT LIMITED TO THE MANIPULATIONS OF THE RECITED STEPS, ONLY THE STRUCTURE IMPLIED BY THE STEPS. Regardless, McCarthy still discloses the recited steps with regards to the connection between the claimed filter cloth and the tray, and if not for any reason later determining that McCarthy doesn’t explicitly disclose the claimed product-by-process steps, it is the Examiner’s position that the structure of McCarthy is substantially the same as the resulting structure from the Applicant’s claimed steps, i.e. a fusion of the filter cloth to the tray frame.
McCarthy does not teach the following limitations:
1) The filter cloth having a passage opening, through which a measuring sensor sleeve is passed or on which it rests, wherein the measuring sensor sleeve has a connecting edge, which surrounds an entrance opening, for the insertion of a temperature sensor.
2) The filter cloth being sealingly fused and pressed with the passage opening with “the adjoining material” of the measuring sensor sleeve using heated tool welding.
With regards to the first limitation not met by McCarthy, Mueller discloses a container for freeze-drying (see abstract) with a filter cloth (vapor permeable sheet 3, 1) having a passage opening (port 28, Fig. 7; col. 13, lines 27-29), through which a measuring sensor sleeve (guide tube 47, Fig. 7) is passed or on which it rests, wherein the measuring sensor sleeve has a connecting edge (seal 34, Fig. 7), which surrounds an entrance opening (sealing lip 52, Fig. 7), for the insertion of a temperature sensor (temperature probe 4, Fig. 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify McCarthy by applying the teachings of Mueller to McCarthy, i.e. incorporating a passage opening into the filter cloth, through which a measuring sensor sleeve is passed or on which it rests, wherein the measuring sensor sleeve has a connecting edge, which surrounds an entrance opening, for the insertion of a temperature sensor, to provide a means to monitor the temperature of the drying material for optimal temperature control, and without contaminating the temperature probe or the drying material (col. 2, lines 51-62 and col. 13, lines 38-43).
With regards to the second limitation not met by McCarthy, it would have been obvious to one of ordinary skill in the art to also sealingly fuse and press (similar to how the filter cloth 105 is sealing fused and pressed along the outer edge of frame 101 using heated tool welding) the filter cloth around the passage opening with “the adjoining material” (see 112b rejection above) of the measuring sensor sleeve using heated tool welding, in order to create an effective seal and attachment (see page. 33 of McCarthy, line 21 – “hermetic closure.”). Moreover, this would be a duplication of parts (i.e. duplicating the welding + pressing feature) which has been held to be obvious unless a new and unexpected result is produced. Also pressing and welding the filter cloth around the passage opening with the adjoining material of the measuring sensor sleeve to create another hermetic seal wouldn’t be a new or unexpected result, since this type of seal is already taught by McCarthy at the cloth and the tray’s outer edge.
Regarding Claim 2, McCarthy as modified above discloses the freeze-drying tray of claim 1,
McCarthy as modified above does not teach the freeze-drying tray characterized in that opposing edges of the first projection (i.e. the first internal upper skirt rim area 119, Fig. 1) are connected to each other via at least one transverse bar (cross members 115, Fig. 1), preferably in a cruciform shape (see Fig. 1),
However, McCarthy as modified above does not teach that the at least one transverse bar has a passage opening, which corresponds to the passage opening of the filter cloth and through which the measuring sensor sleeve is passed or on which it rests in a sealing manner.
Mueller teaches a freeze-drying container (see abstract) with support braces 25, Fig. 2c that have a passage opening (port opening 26, Fig. 5c; see also Figure 2 which shows the port openings 26 on the support braces 25), which corresponds to the passage opening of the filter cloth (see Fig. 5c) and through which the measuring sensor sleeve is passed or on which it rests in a sealing manner (col. 18, lines 5-10).
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 McCarthy by further applying the teachings of Mueller to McCarthy, i.e. incorporating a passage opening on the at least one transverse bar, and modifying the passage opening of the filter cloth so that it corresponds (align) to the passage opening of the filter cloth, for the predictable benefit of a stable and secure connection of the sensor and sensor sleeve, as one of ordinary skill in the art would recognize.
Regarding Claim 3, McCarthy as modified above discloses the freeze-drying tray of claim 1, characterized in that a screw connection (screw cap 50 with a through hole, Fig. 7; see col. 13 line 31) is assigned to the measuring sensor sleeve (i.e. guide tube 47) for a precisely positioned fastening of a temperature sensor (i.e. temperature probe 48).
Regarding Claim 4, McCarthy as modified above discloses the freeze-drying tray according to claim 3, characterized in that the screw connection is a conduit (see col. 13, line 31 – the screw cap 50 “with a through hole,” which is a conduit) thread (see Figure 7, the screw cap 50 has threading to engage with connector 38).
McCarthy as modified above does not disclose that the screw connection is steel.
However, it’s the examiner’s position that steel is a very well-known and conventional material that is used for threaded fasteners, since steel is very strong and durable.
Therefore, 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 conduit thread to be steel for these known benefits.
Regarding Claim 5, McCarthy as modified above discloses the freeze-drying tray of claim 1, characterized in that the tray frame and/or the measuring sensor sleeve are produced in each case from polyethylene, polypropylene or polyester (pg. 17, line 20-25).
Regarding Claim 7, McCarthy as modified above discloses the freeze-drying tray of claim 1, characterized in that the filter cloth is produced from a polytetrafluorethylene membrane (pg. 33, lines 1-5 – “a nanoporous semi-permeable hydrophobic membrane material that is composed of nanoporous polytetrafluoroethylene”), which is laminated on a polytetrafluorethylene carrier (pg. 33, lines 1-5).
Regarding Claim 8, McCarthy as modified above discloses the freeze-drying tray of claim 1, characterized in that the filter cloth is made of a polytetrafluorethylene membrane (pg. 33, lines 1-5), which is laminated on a carrier made of polyethylene, polypropylene or polyester (pg. 33, lines 1-10 – “nanofiber polyethylene… nanofiber polypropylene…”).
Regarding Claim 9, McCarthy as modified above discloses the freeze-drying tray according to Claim 1, characterized in that the tray frame has, on its side opposite from the first projection, another free edge with a second projection (outward peripheral base rim 120, Fig. 1), on which a cover film (impermeable base film 106) is affixed.
Regarding Claim 10, McCarthy as modified above discloses the freeze-drying tray according to Claim 1, characterized in that the cover film is produced from the same material as the tray frame (pg. 33 lines 1-10 and pg. 36, lines 23-26).
Regarding Claim 11, McCarthy as modified above discloses the freeze-drying tray according to Claim 1, characterized in that the tray frame forms a closed cover on its side opposite from the first projection (via the placement of rigid lid 103).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over McCarthy et. al. (WO2014165222 cited in the Applicant’s IDS filed on 11/21/2024, hereinafter McCarthy) as applied to claims 1-2, 5, and 7-11 above in view of Mueller et. al. (US11377276 cited in the Applicant’s IDS filed on 11/21/2024, hereinafter Mueller), and further in view of Li et al. (CN102200372, hereinafter Li).
Reference is made to the attached Chinese to English translation of Li ‘372.
Regarding Claim 6, McCarthy as modified above discloses the freeze-drying tray of claim 1.
McCarthy does not teach the measuring sensor sleeve having a metallic contact surface on its free end.
Mueller discloses a freeze-drying container (see abstract), comprising a measuring sensor sleeve (guide tube 47, Fig. 7) having a metallic contact surface on its free end (col. 13, lines 29-30 and lines 36-43).
Mueller’s disclosed measuring sleeve has a contact surface at its free end, that is in contact with the container body which is metallic (col. 8, lines 1-2). This contact is necessary for obtaining temperature readings (col. 13, lines 36-43).
The contact surface of the measuring sensor sleeve is not explicitly disclosed to be metallic as claimed. However, the reference specifically states that the measuring sensor sleeve is made from a material with “good thermal conductivity” (col. 13, lines 29-30).
It is the Examiner’s position that since the container body is disclosed as being metallic, and the measuring sensor sleeve is disclosed as being made from a material with “good thermal conductivity” and the contact between the container body and the measuring sensor sleeve is for obtaining temperature readings, then one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the measuring sensor sleeve’s contact surface to also be made from the same material as the container body, for the predictable benefit and result of effectively obtaining temperature measurement readings based on the thermal conductivity readings (i.e. the heat conducted between the bottom of the guide tube and the container body).
Additionally, the reference to Li discloses a microwave vacuum freeze-drying device (see abstract), characterized in that the measuring sensor sleeve has a metallic contact surface on its free end (temperature sensor 36 with metal shielding 362, see Fig. 7).
It is the Examiner’s position that the metal shielding functions similarly to the measuring season sleeve, in that it holds a temperature sensor in contact with the drying material to provide a known means of monitoring temperature data during the freeze-drying process (pg. 6, para 007).
Therefore, 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 measuring sensor sleeve taught by McCarthy as modified by Mueller to have a metallic contact surface as taught by Li, for the predictable benefit and result of accurately measuring the temperature of a drying material via thermal conductivity between the metallic contact surface and the bottom of the tray during freeze-drying.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANEISA SAVEENI JANGBAHADUR whose telephone number is (571)272-0813. The examiner can normally be reached Monday-Friday, 8 a.m.- 5 p.m. ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hoang can be reached at 571-272-6460. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANEISA SAVEENI JANGBAHADUR/Examiner, Art Unit 3762 /MICHAEL G HOANG/Supervisory Patent Examiner, Art Unit 3762
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