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 .
Response to Amendment
The amendment filed on August 28, 2025 is acknowledged. Claims 3, 5-9, 11-14 and 19-22 are pending. Applicant amended claims 3, 5-9, 11-14, 19 and 20, and added new claims 21 and 22.
Response to Arguments
Despite the amendment necessitating the new grounds of rejection set forth below, Applicant’s arguments directed to the patentability of the claims remain pertinent. That said, Applicant’s arguments have been fully considered, but they are not persuasive.
Applicant argues that the claims are patentable over the combination of Buchanan and Kieselbach because independent claim 9 has been amended to recite a step of “determining the predetermined time interval by drying at least one test sample at vacuum at the elevated temperature using the apparatus while monitoring a test pressure in the sample-receiving area, wherein the predetermined time interval is defined when a change in the test pressure over time remains below a predetermined limit value”, which is not taught or suggested by the combination (Remarks 7-8). The argument is not persuasive. As acknowledged by Applicant (Remarks 8), Kieselbach teaches the use of a predetermined time interval for vacuum drying an analytical sample, wherein the predetermined time interval is based on drying times of “similar mixtures and quantities under laboratory conditions” (i.e. a test sample) (Remarks 8 and lines 27-29, col. 6 of Kieselbach). While Kieselbach does not explicitly disclose the pressure conditions (test pressure) under which the “similar mixtures and quantities” are dried, it would have been obvious (if not evident) to determine the predetermined time interval on identical drying parameters of the test sample and the analytical sample. Otherwise, the predetermined time interval would have minimal utility. That said, given that the operating parameters of the analytical sample taught by Kieselbach include maintaining constant pressure during drying (see lines 22-23, col. 6 disclosing “temperature and pressure are maintained at this level”), it would have been obvious (if not evident) to define the predetermined time interval when a change in the test pressure over time is constant (i.e. remains below a predetermined limit value).
For the foregoing reason, Applicant’s argument that the amendment to claim 9 patentably distinguishes the claimed invention from the combination of Buchanan, Kieselbach and Wulf is not persuasive.
Claim Objections
Claims 3, 5-9, 12, 13 and 20-22 are objected to because of the following informalities:
Independent claim 9 was amended to introduce “an analysis sample” in the preamble, and the body of the claim was amended to reflect this introduction (e.g. later recitation of “the sample” was amended to “the analysis sample”). However, many instances of the limitation “sample” were not amended. Consequently, the claim now recites an “analysis sample” and a separate “sample” (e.g. see “a sample”). The claims should be amended to refer to a singular sample.
Appropriate corrections are required throughout the claims.
Applicant is advised that should claim 8 be found allowable, claim 22 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 8 and 22 are verbatim identical.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 3, 5-9, 11-14 and 19-22 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
Independent claim 9 was amended to add a step of “determining the predetermined time interval by drying at least one test sample at vacuum at the elevated temperature using the apparatus while monitoring a test pressure in the sample-receiving area”. The originally filed specification fails to provide support for the amendment. Contrary to Applicant’s remarks (Remarks 8), [0033], [0047] and Fig. 2 of the specification do not disclose or suggest a step of using a test sample to determine the predetermined time interval. Consequently, the amendment constitutes new matter.
Claims not explicitly rejected are rejected due to dependency.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 3, 5-9, 11-14 and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Buchanan et al. (“Buchanan”) (US 2002/0128468 A1) in view of Kieselbach et al. (“Kieselbach”) (US 5,937,536) and Wulf (DE 19526959 A1).
With respect to claim 9, Buchanan discloses a method for preparing an analysis sample for a subsequent analysis by MALDI in combination with mass spectrometric analysis (see [0090]), the method comprising:
-providing an apparatus (vacuum oven) comprising:
a sample-receiving area surrounded by a housing and defining an internal volume closed off from the surroundings (it is evident that a vacuum oven must comprise a housing, and it must define a sample-receiving area within an internal volume of the housing, wherein the internal volume must be closed off from the surroundings in order to produce a vacuum inside the housing);
a heating unit configured to heat at least the sample-receiving area to an elevated temperature (see [0090] disclosing that the drying occurs at 50 degrees Celsius), wherein the heating unit must be either connected to the housing or arranged in the housing in order to heat the housing, wherein the heating unit is configured to heat the housing such that the analytical sample in the sample-receiving area is heated indirectly via the housing (an oven heats via convection); and
a vacuum device configured to generate a vacuum in the sample-receiving area (see [0090]);
-preparing the analysis sample by:
introducing the sample into the sample-receiving area (see [0090]);
heating the sample-receiving area surrounding the analysis sample indirectly via the housing with the heating unit (see [0090]); and
during a predetermined time interval, generating a vacuum in the heated sample-receiving area such that the drying of the analytical sample is performed in a vacuum at the elevated temperature without damaging the sample (see [0090] disclosing drying at 50 degrees Celsius).
The method differs from the claimed invention in that Buchanan does not disclose any structural features of the oven. Naturally, Buchanan does not disclose:
a loading/unloading device configured to enable automatic introduction of the analysis sample into the sample-receiving area and automatic removal of the analysis sample from the sample-receiving area;
a pressure sensor configured to determine a pressure in the sample-receiving area; or
a step of using the pressure sensor and a test sample to determine the predetermined time interval.
Regarding the automatic loading/unloading device, Wulf discloses a vacuum drying chamber for drying chemical and pharmaceutical samples (see second paragraph of translation). The chamber comprises a loading/unloading device that automatically conveys a sample from outside the drying chamber into a sample-receiving area of the chamber and to convey the sample from the sample-receiving area to the outside (see Figs. 1 and 3). In light of the disclosure of Wulf, it would have been obvious to one of ordinary skill in the art to provide the Buchanan apparatus with an automated loading/unloading device. The modification would enable automatic loading and unloading of analytical samples from the oven, offering convenience and limiting the potential for contamination associated with manual handling of analytical samples. Naturally, the Buchanan method modified pursuant to the teachings of Wulf would comprise a step of automatically introducing the analytical sample into the sample-receiving area.
Regarding the use of a pressure sensor, given that the drying taught by Buchanan is accomplished using vacuum, it would have been obvious to one of ordinary skill in the art to provide the vacuum oven with a pressure sensor so that pressure inside the vacuum oven can be monitored and controlled, as taught by Kieselbach (see lines 51-52, col. 4 and line 62, col. 2 disclosing using a pressure sensor 29 to precisely control pressure inside a vacuum oven).
Regarding the use of a test sample, Kieselbach further teaches the use of a test sample to establish a predetermined time interval for drying an analytical sample such that the analytical sample can be dried with efficiency and without damaging the analytical sample (see lines 27-29, col. 6). Moreover, as discussed above (see Response to Arguments), it would have been obvious to one of ordinary skill in the art to determine the predetermined time interval based on operating parameters of the analytical sample being equal to the operating parameters of the test sample, meaning that the predetermined time interval would be determined during a period in which the change in a test pressure over time remains below a predetermined limit value (i.e. time during which the test pressure remains constant) (see lines 22-23, col. 6 of Kieselbach). In light of the disclosure of Kieselbach, it would have been obvious to one of ordinary skill in the art to further include in the modified Buchanan method, a step of determining the predetermined time interval by drying a test sample of similar composition and quantity to the analytical sample while monitoring a test pressure, wherein the predetermined time interval is defined during a time which a change in the test pressure remains constant during the drying process (i.e. a below a predetermined limit value). The modification would ensure that the predetermined time interval is optimal for drying the analytical sample.
With respect to claim 3, Kieselbach also discloses that the temperature of its oven is controlled (see line 51, col. 2), meaning the oven must comprise a temperature sensor. In light of the disclosure of Kieselbach, it would have been obvious to one of ordinary skill in the art to further provide the Buchanan oven with a temperature sensor configured to determine the temperature of the housing, the sample-receiving area, or the sample so that the drying process can be precisely controlled.
With respect to claim 5, as discussed above (see rejection of claim 9), the modified Buchanan apparatus would comprise an automated loading/unloading device for automatic loading and unloading of analytical samples from the oven.
With respect to claim 6, it is evident that the oven taught by Buchanan must comprise an opening for introducing the sample into the oven, and a means to seal the opening during operation. Otherwise, it would be impossible to generate a vacuum inside the housing. That said, it would have been obvious to one of ordinary skill in the art to further provide the oven with a cover configured to seal said opening, and hence the sample-receiving area from the surroundings, when the sample is disposed in the sample-receiving area (see also Fig. 1 of Kieselbach illustrating a door for sealing the oven).
With respect to claim 7, the loading/unloading device of the modified Buchanan apparatus would automatically introduce the sample into the sample-receiving area, as discussed above.
With respect to claims 8 and 22, the loading/unloading device of the modified Buchanan apparatus would automatically introduce and remove the sample into and from the sample-receiving area, as discussed above. Naturally, automated removal of the sample would be facilitated by the computer of the oven after the predetermined time interval.
With respect to claims 11 and 12, as discussed above, the drying is conducted at a predetermined elevated temperature. Naturally, the sample-receiving unit must be heated to said predetermined elevated temperature with a predetermined heating power of the heating unit. Moreover, it would have been obvious, if not evident, to select the predetermined elevated temperature as a function of the properties (quantity, moisture content) of the sample to optimize the drying process.
With respect to claim 13, as discussed above (see rejection of claim 9), the predetermined time interval is based on drying a test sample “similar mixture and quantity” as the analytical sample, meaning the predetermined time interval is a function of the quantity of the sample.
With respect to claims 14 and 19, as discussed above (see rejection of claim 9), Kieselbach teaches defining the predetermined time interval during a time in which pressure is constant over a period of time, meaning the predetermined time interval is a function of a time curve of pressure in the sample-receiving area.
With respect to claim 20, given that the loading/unloading device of the modified Buchanan apparatus would be automated (see rejection of claim 9), the method would further comprise a step of using the loading/unloading device to automatically remove the analytical sample from the sample-receiving area after the time interval so that the analytical sample can be analyzed using MALDI in combination with mass spectrometry.
With respect to claim 21, as discussed above (see rejection of claim 9), the at least one test sample is of “similar mixture” (i.e. substantially the same composition) as the analytical sample.
Conclusion
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 PAUL S HYUN whose telephone number is (571)272-8559. The examiner can normally be reached M-F 8:30-5:00.
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/PAUL S HYUN/Primary Examiner, Art Unit 1796