FINAL REJECTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Claims 1-15 and 17-18 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Birolini et al. (US 2014/0241959 Al, cited by Applicants, “Birolini”).
Regarding Claim 1, Birolini teaches an archiving method for archiving in a cold storage [0001], at least one sample tube containing a biological sample using at least one tube rack [0022], the method comprising the following steps: receiving, by a computing system (fig.1; element 60), a request for archiving the at least one sample tube ([0067]: “depending on a request made by an operator”), placing the at least one sample tube in at least one receptacle of the at least one tube rack to receive the at least one sample tube ([0109]: “operator places tubes 10 in the positions P on the rack enlightened by the lighting means 71”), recording and/or updating, in a memory unit of the computing system (a memory is in the processing unit 60, [0052]), sample-tube-storage-data including sample tube data and/or tube rack data and/or storage data ([0063]-[0064]: “associating in a secondary memory 64 such coordinates and such position Pt; … mapping the detected tube 10 into a corresponding tube position P'”), and storing the at least one tube rack in the cold storage (Implicit in [0002] as it discloses, “managing insertion and retrieval of racks and tubes within the racks in a specific work area.” As to “cold storage”, Birolini discloses a system for the management of racks and tubes position for clinical chemistry analysis laboratories [0001]. It is known in the art that the clinical chemistry analysis laboratories utilize cold storage to store biological/lab samples.).
Regarding Claim 2, the method according to claim 1 is taught by Birrolini.
Birolini further teaches wherein the sample tube data include at least one of an identifier (fig.1a; element TID) of the at least one archived sample tube [0046], sample tube expiration data and patient-related data, and/or wherein the tube rack data include at least one of an identifier of the at least one stored tube rack, tube rack expiration data, patient-related data and occupation data of the at least one tube rack, and/or wherein the storage data include at least one of an identifier of the storage and a location of the at least one tube rack stored in the storage ([0046]: "scanning the tube identifier"; [0072]: “the auxiliary memory module 90 comprises additional data D about the tubes 10 and/or racks 20 in the system").
Regarding Claim 3, the method according to claim 1 is taught by Birrolini.
Birolini further teaches wherein the method further comprises: arranging the at least one sample tube to be archived at a scanning position of an apparatus being communicatively coupled with the computing system and configured to interact with the at least one tube rack before the at least one tube rack is stored in the storage, scanning, by the apparatus, the at least one sample tube when arranged at the scanning position with respect to the apparatus ([0039-0040]: scanning camera 40), visually indicating , based on the scan and the request, the at least one tube rack to be stored and/or the at least one receptacle of the at least one tube rack in which the at least one sample tube is to be placed and/or the storage where the at least one tube rack is to be stored, the computing system receiving user input as to a location in the storage where the at least one tube rack is stored and/or the computing system receives user input to record the sample-tube-storage-data ([0039-0040]: scanning camera 40, [0100]: displaying means 80; [0090]: “The indicating means 70 are configured for indicating at least an allowed inserting position P'”).
Regarding Claim 4, the method according to claim 3 is taught by Birrolini.
Birolini further teaches wherein the computing system comprises a display screen ([0100]: displaying means 80), and the request for archiving is received via the computing system and/or the apparatus and displayed on the display screen of the computing system, wherein the computing system is a tablet PC ([0090]: “The indicating means 70 are configured for indicating at least an allowed inserting position P'”; [0048]).
Regarding Claim 5, the method according to claim 3 is taught by Birrolini.
Birolini further teaches wherein the visually indicating includes: illuminating the at-least one tube rack to be stored and/or the at least one receptacle of the at least one tube rack in which the at least one sample tube is to be placed and/or the storage where the at least one tube rack is to be stored, and/or displaying the sample tube data and/or the tube rack data and/or the storage data on a display screen ([0087-0089]).
Regarding Claim 6, the method according to claim 1 is taught by Birrolini.
Birolini further teaches wherein the method further comprises: indicating, by the computing system [0048], based on the sample-tube-storage-data, that the at least one archived sample tube and/or the at least one stored tube rack is to be retrieved from the storage, wherein the indicating includes: prompting an alert that the at least one archived sample tube and/or the at least one stored tube rack is to be retrieved from the storage (implicitly taught in [0083]; [0099]-[0102]).
Regarding Claim 7, Birolini teaches a retrieving method for retrieving at least one sample tube containing a biological sample from at least one tube rack stored in a cold storage ([0002] & [0100]: “the system for management of racks and tubes position comprises a retrivial interface 81, preferably on the displaying means 80, configured for receiving a request R of types of tubes 10 to be retrieved'”), the method comprising the following steps: receiving [0100], by a computing system (fig.1; element 60), a request for retrieving the at least one sample tube ([0100]: “Request R”), upon the request, obtaining, from a memory unit of the computing system, sample-tube-storage-data including sample tube data and/or tube rack data and/or storage data ([0101]: “indicating means 70 are configured for indicating tube positions P as a function of said request R received by said retrieval interface 81”), based on the sample-tube-storage-data, retrieving the at least one tube rack from the storage and retrieving the at least one requested sample tube from at least one receptacle (implicit in [0101] as disclosed “"retrieval interface 81 provides a visual user-friendly interface and an operator can select the tubes 10 he wants to be retrieved'”), and after retrieving the at least one requested sample tube, updating the sample-tube-storage-data ([0048] discloses “A processing unit 60 … is configured for automatically check if the tubes 10 on the rack 20 are still present.” [0001] discloses “a system for the management of racks and tubes position.” Thus, the limitation is implicitly taught by Birolini as the detection that the tube is no longer present must trigger an update of the corresponding data. As to “cold storage”, Birolini discloses a system for the management of racks and tubes position for clinical chemistry analysis laboratories [0001]. It is known in the art that the clinical chemistry analysis laboratories utilize cold storage to store biological/lab samples.).
Regarding Claim 8, the method according to claim 7 is taught by Birrolini.
Birolini further teaches wherein the sample tube data include at least one of an identifier (fig.1a; element TID) of the at least one archived sample tube [0046], sample tube expiration data and patient-related data, and/or wherein the tube rack data include at least one of an identifier of the at least one stored tube rack, tube rack expiration data, patient-related data and occupation data of the at least one tube rack, and/or wherein the storage data include at least one of an identifier of the storage and a location of the at least one tube rack stored in the storage ([0046]: "scanning the tube identifier"; [0072]: “the auxiliary memory module 90 comprises additional data D about the tubes 10 and/or racks 20 in the system").
Regarding Claim 9, the method according to claim 7 is taught by Birrolini.
Birolini further teaches wherein the method further comprises: providing, by the computing system (fig.1; element 60), the request to an apparatus being communicatively coupled with the computing system and configured to interact with the at least one tube rack before retrieving the at least one sample tube from the at least one tube rack, and visually indicating, based on the sample-tube-storage-data, the storage where the at least one tube rack is stored and/or the at least one tube rack from which the at least one sample tube is to be retrieved and/or the at least one receptacle of the at least one tube rack from which the at least one sample tube is to be retrieved [0099-0101].
Regarding Claim 10, the method according to claim 9 is taught by Birrolini.
Birolini further teaches wherein the method further comprises: positioning the at least one tube rack on a holding unit of the apparatus, wherein the visually indicating includes illuminating at least one of the receptacles of the tube rack positioned on the apparatus by at least one light emitting diode ([0107] discloses LEDs, Fig.1a; element 70).
Regarding Claim 11, the method according to claim 9 is taught by Birrolini.
Birolini further teaches wherein the computing system and/or the apparatus comprises a display screen ([0100]: displaying means 80) and the request for retrieving is received via the display screen of the computing system, wherein the computing system is a tablet PC, ([0090]: “The indicating means 70 are configured for indicating at least an allowed inserting position P'”) wherein the sample-tube-storage-data is displayed on the display screen before retrieving the at least one sample tube from the storage ([0092]: “The indicating means 70 are configured for indicating at least an allowed inserting position P'”; [0048]).
Regarding Claim 12, Birolini teaches a laboratory system (implicit in [0001]; [0010]) including a computer system or being operatively coupled to a computer system ([0048]; [0056]) which is adapted to carry out the method of claim 1 as taught by Birrolini.
Regarding Claim 13, Birolini teaches a computer program product comprising computer executable instructions stored on a non-transitory computer readable medium ([0048]; [0056]), which when executed by a computer processing device of a computer system of a laboratory system (implicit in [0001]; [0010]), cause the laboratory system to carry out the method according to claim 7 as taught by Birrolini.
Regarding Claim 14, Birolini teaches a tube rack (Fig.1b) for receiving at least one sample tube containing a biological sample ([0001]; [0023]), the tube rack comprising: a body having a surface which is substantially planar in a horizontal direction (shown in fig.1b), wherein the surface has at least one receptacle to receive the at least one sample tube (10, fig.1b), and at least one optical indicator (fig.2a-2c; element 72) configured to visually indicate the at least one receptacle and/or the tube rack (fig.2a-2c; [0112]-[0123]).
Regarding Claim 15, the tube rack according to claim 14 is taught by Birrolini.
Birolini further teaches wherein the at least one optical indicator is a display for displaying tube rack data and/or sample tube data; and/or wherein the at least one optical indicator is a light emitting diode; and/or wherein the at least one optical indicator is powered inductively; and/or wherein the at least one optical indicator is disposed at the body of the tube rack [0107].
Regarding Claim 17, the method according to claim 9 is taught by Birrolini.
Birolini further teaches wherein the method further comprises: arranging the at least one sample tube retrieved from the at least one tube rack at a scanning position of the apparatus, scanning, by the apparatus (by a reading means 50, [0035]; [0058]), the at least one sample tube when arranged at the scanning position with respect to the apparatus (The reading means 50 comprise one or more among a linear barcode scanner), and confirming, by the apparatus, based on the scan and the request, that the at least one requested sample tube has been retrieved ([0098]-[0100]).
Regarding Claim 18, the tube rack according to claim 14 is taught by Birrolini.
Birolini further teaches wherein the tube rack comprises a data storage element (90) configured to store sample tube data and/or tube rack data ([0072]; claim 2).
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Birolini in view of Cohen (US 2014/0172154 A1).
Regarding Claim 16, the method according to claim 1 is taught by Birrolini.
Birolini does not explicitly teach wherein the method further comprises indicating, by the computing system, based on the sample-tube-storage-data, that the at least one archived sample tube and/or the at least one stored tube rack and/or the biological sample contained in the at least one archived sample tube is expired.
However, Cohen teaches sample container or sample container holder storage systems [0002] wherein the method further comprises indicating, by the computing system, based on the sample-tube-storage-data, that the at least one archived sample tube and/or the at least one stored tube rack and/or the biological sample contained in the at least one archived sample tube is expired ([0069] teaches that the destocking time may correspond to the expiration dates of the specimens in the sample containers. Then, in step 206, the central controller software generates a list of samples to destock from data in the database (step 206).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Birolini’s method with the teaching of Cohen since both arts are analogous and it is known in the art to identify expiration date of a sample tube. This expiration identification would provide an updated and precise management of sample container holder storage systems/methods.
Response to Arguments
Applicant's arguments filed on 06/01/2026 with respect to claims 1-15 have been considered but they are not persuasive. Due to the current amendment to Claims, the Objection to Claims is withdrawn.
(a) With regards to claim rejections of claim 1 under 35 U.S.C. 102 applicant argues in page 7:
“Turning first to claim 1, the applicant notes that that claim recites "storing the at least one tube rack in the cold storage." In rejecting claim 1, the Office Action asserted that storing the at least one rack in the storage was implicitly taught by the disclosure of "managing insertion and retrieval of racks and tubes within the racks in a specific work area" from paragraph 2 of Birolini. In response, the applicant submits that this cannot justify the rejection of claim 1. …. Accordingly, the applicant submits that Birolini cannot properly be treated as teaching "storing the at least one tube rack in the cold storage,".”
(b) With regards to claim rejection of claim 7 under 35 U.S.C. 102 applicant argues in page 8-9:
“Turning next to claim 7, the applicant notes that that claim recites "based on the sample-tube-storage-data, retrieving the at least one tube rack from the storage and retrieving the at least one requested sample tube from at least one receptacle." In rejecting claim 7, the Office Action asserted that this was implicitly disclosed by "retrieval interface 81 provides a visual user-friendly interface and an operator can select the tubes 10 he wants to be retrieved" from paragraph 101 of Birolini. However, the applicant submits that this cannot justify the rejection of claim 7 at least because claim 7 requires retrieving both at least one tube rack from storage and at least one tube from a receptacle, and Birolini's retrieval interface addresses only tubes to be retrieved, without indicating that at least one tube rack would also be retrieved from storage. Indeed, Birolini indicates that that the tubes selected in the retrieval interface would be retrieved from a rack, implying that the rack would not be retrieved at all.”
(c) With regards to claim rejection of claim 14 under 35 U.S.C. 102 applicant argues in pages 9-10:
“Turning next to claim 14, the applicant notes that that claim recites "A tube rack for receiving at least one sample tube containing a biological sample [which comprises] at least one optical indicator configured to visually indicate that the at least one receptacle and/or the tube rack." In rejecting claim 14, the Office Action asserted that the recited optical indicator was taught by element 72 as illustrated in figures 2a-2c of Birolini. However, as Birolini itself makes clear, element 72 is not comprised by a tube rack. Instead, element 72 is one or more light emitting diodes on a lower body of a support which would hold a rack on its separate upper surface. Accordingly, the applicant submits that the rejection of claim 14 should be reconsidered and withdrawn at least because Birolini does not teach a tube rack comprising at least one optical indicator as recited in claim 15.”
The examiner respectfully disagrees.
The requirement for a proper response to a rejection may be found in 37 CFR 1.111(b) and MPEP § 707.07. The requirements for obviousness are discussed in MPEP § 2142. The requirements for broadest reasonable interpretation are discussed in MPEP 2111.01 (I) and 2173.01(I). The requirements for analogous art are discussed in MPEP 2141.01(a)(I). As to claim interpretation, MPEP 2111.01 (I) states “[U]nder a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. The plain meaning of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the time of the invention or as of the effective filing date of the patent application.” As to analogous art, MPEP 2141.01(a)(I) discloses “[R]ather, a reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). See Bigio, 381 F.3d at 1325.”
Examiner’s explanation:
(a) The examiner respectfully disagrees. As to “cold storage”, Birolini discloses a system for the management of racks and tubes position for clinical chemistry analysis laboratories [0001]. It is known in the art that the clinical chemistry analysis laboratories utilize cold storage to store biological/lab samples. The applicant discloses, “The present invention relates to an archiving method for archiving in a storage, in particular in a cold storage, at least one sample tube containing a biological sample ….” [0001]. Birolini art teaches “The system for the management of racks and tubes position for clinical chemistry analysis laboratories of the invention comprises tubes capable of containing human biological material (specimen),” [0022]. Thus, the Birolini art is applicable in the same working environment (such as, cold storage) as disclosed in the claimed invention. Thus, the present art implicitly teaches the limitation.
(b) As to arguments regarding rejection of claim 7, [0101] discloses “retrieval interface 81 provides a visual user-friendly interface and an operator can select the tubes 10 he wants to be retrieved.”). Para. [0048] discloses “A processing unit 60 … is configured for automatically check if the tubes 10 on the rack 20 are still present.” [0001] discloses “a system for the management of racks and tubes position.” To retrieve a tube from a rack, one must retrieve the rack first. Thus, retrieval of a rack is an obvious step in retrieving a tube from the rack. Therefore, Birolini implicitly teaches the limitations.
(c) As to claim 14, [0112] discloses that the lighting means 71 comprise a plurality of single LEDS 72 independently mounted on said lower body 31 under the whole area of the upper surface 32, as depicted in fig.2a. [0113] discloses that each LED 72 can be mounted or removed from the lower body 31 independently from the others. Thus, at least one optical indicator configured to visually indicate the at least one receptacle. With the limitation “and/or” in the claim, meeting either of the “and” or “or” option would be sufficient. Since at least one option is taught by Birolini, Birolini teaches the claim limitations.
For at least the foregoing reasons, the rejection under 35 U.S.C. §102 is maintained since under a broadest reasonable interpretation, the present arts teach the claimed limitation.
Conclusion
The following prior arts made of record and not relied upon, are considered pertinent to applicant's disclosure:
Lackner et al. (US 2010/0028124 A1) teaches a laboratory storage and retrieval system and a method to handle laboratory sample tubes. The system comprises a rack handler section (12) and a storage section (14), the rack handler section (12) comprising a transport system and a determination unit, wherein the transport system receives and transports incoming primary racks (PR) containing sample tubes (S) to the determination unit for determining at least one given parameter of the sample tubes (S) relating to predetermined sort criteria in order to have the transport system unload the sample tubes from the analysed primary rack (PR) and resort the unloaded sample tubes into appropriate storage racks (SR) [Abstract].
THIS ACTION IS MADE FINAL. 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUMAN NATH whose telephone number is (571)270-1443. The examiner can normally be reached on M to F 9:00 am to 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JOHN BREENE can be reached on 571-272-4107. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUMAN K NATH/Primary Examiner, Art Unit 2855
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