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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “multiple operation units”, “at least one multi-axis robot”, “culture and lysis unit”, “purification unit” and quality control unit” in claim 1, “track” in claim 2, a “multi-axis robot that includes a robot arm”, a “holding means for tube and bottle”, a “capping/decapping means”, a “shaking mechanism”, “one or more liquid dispensing units”, and “sensor(s) for receiving signals from the multiple operation units”, “one or more centrifuges”, “one of more column tray”, and “DNA columns” in claim 4 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: the Brief Description of the Drawings section contains reference to Fig. 1. However, the Figures include Fig. 1A and Fig. 1B. The examiner recommends the Brief Description of Drawing section include description of both Fig. 1A and 1B.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) include:
i. “a culture and lysis unit” in claim 1, which has been interpreted by the examiner as corresponding to a sequence of incubators with shaking racks, one or more centrifuges, and at least one sterilizer, as set forth in claim 4 or structural equivalents thereof.
ii. “a purification unit” in claim 1, which has been interpreted by the examiner as corresponding to one or more vacuum manifolds, one or more centrifuges and one or more column trays including DNA columns, each column including at open upper end, an open lower end, a solid phase and a filter above the solid phase”, as set forth in claim 4 or structural equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-18 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 discussed above, in claim 1 the limitations “a culture and lysis unit” and “a purification unit” have invoke interpretation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (see item 6 above). However, the A and B units have been interpreted to include at least one or more centrifuges. It is unclear which “at least one or more centrifuges” correspond to which unit, therefore, the claim is confusing and indefinite.
The recitation “A) culture and lysing unit” in claim 4 should be changed to --the A) culture and lysis unit-- for antecedent basis with claim 1.
Claim 2 recites “the multi-axis robot”, this should be amendment to --at least one multi-axis robot--.
Claim 3, last line, recites “sensor(s)”. It is not clear if this includes “at least one sensor”.
Claims 4 and 8 recite “a sequence of incubators”. It is not clear what applicant means by “a sequence” of incubators. The examiner believes this should recite --a plurality of incubators-- for clarity. In addition, the recitation “with shaking rack(s)” is unclear as to whether each sequence of incubators includes a plurality of shaking racks or one rack. The use of “rack(s)” is not definite.
Claim 5 recites “an automated plasmid preparation system comprising one or more of the automated integrated plasmid preparation module of claim 1”. The recitation “automated integrated plasmid preparation module” lacks antecedent basis. Furthermore, it is unclear how the “system” claim 5 differs structurally from the “module” of claim 1, since the scope of the claimed system includes “one automated plasmid preparation module”, which is not a system since both claims 1 and 5 merely require one module. Also “one or more of the automated (integrated) plasmid preparation module(s) of the claim 1 do not agree in number since claim 1 only requires a single automated plasmid preparation module.
Claim 6 recites “a process/method using the automated plasmid preparation system of claim 5, wherein the multi-axis robots are programmed to operate each of the modules simultaneously”. The scope of claims 1 and 5 do not require a plurality of multi-axis robots or more than one module. The method is confusing and indefinite.
Claim 7 recites is directed to another process depending on the system 5, that refers to “the multi-axis robot”. The multi-axis robot recited in claims 7-18 does not agree in number with the “at least one multi-axis robot” in parent claim 1. The scope of claims from which claim 8 depends does not require more than one multi-axis robot. Thus, the scope of the claim 8 cannot be determined. The examiner recommends applicant recite independent system and method claims rather than depend from a different statutory category of invention (apparatus/system vs method).
Claim 8 recites the phrase “gentle shaking”. This is a relative phrase which renders the claim indefinite. The term “gentle” 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. It is not clear what applicant considers “gentle shaking”.
Claim 8 recites “each multi-axis robot is programmed to, a) receive a sequence of incubators each holding a set number of empty culture bottles”. It is not clear what is meant by each robot is programmed to “receive a sequence of incubators”. Claim 8 recites “a) a set number of empty culture bottles” and “retrieving one or more of the culture bottles”. The scope of claim 8 requires a set number, which includes 0 or 1. The rest of the steps do not make sense in the case where 0 or 1 culture bottles are considered. Step c recites “retrieving one or more of the culture bottles”. This does not agree in number with the vague “a set number of empty culture bottles”.
Claims 8 and 9 recite “the supernatant”. This limitation lacks antecedent basis.
Claim 9 recites the robot is programmed to, h) “retrieve equilibrated DNA columns”. The step of equilibrating DNA columns has not been established. Also, DNA columns lack antecedent basis. This confusing and indefinite. Also, “the elute” in step j does not find antecedent basis.
The dependency of claims 13-18 is not clear. For example, claim 13 depends from claim 6, however, “step r” in claim 13 finds no antecedent basis in either claim 6 or 1. Claim 14 recites “after step h)” which lacks antecedent basis. Similar deficiencies were found in claims 15-18, rendering the scope of these claims unclear. Claims 13-18 cannot be examined due to the lack of clarity.
Claim 17 recites “the pellets”. This lacks antecedent basis.
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 (i.e., changing from AIA to pre-AIA ) 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-18, as best understood, are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Ahlfors (WO 2017/221155; see corresponding US 2020/0025782 for citations below).
Regarding claim 1, Ahlfors discloses an automated plasmid preparation module, comprising
multiple operation units comprising at least,
A) a culture and lysis unit for culturing and lysing bacteria transformed with plasmid (corresponds to a plurality of incubators with shaking rack(s), one or more centrifuges, and at least one sterilizer , and
B) a purification unit for obtaining purified plasmid DNA, and
at least one multi-axis robot 700 programmed to control and operate the multiple operation units .
Note: although the claim 1, as currently written, does not require the prior art to disclose the optional quality control unit, Ahlfors discloses a quality control area 500 including one or more quality control units (see para [0149] et seq.)
Also note: that the current scope of the claims do not require any of the “modules” “units” to include in all comprising structures within a single housing. For example, the culture and lysing unit comprises a sequence of incubators, one or more centrifuges, and at least one sterilizer. However, the incubators, centrifuge, and sterilizer do not need to be within the same housing. These limitations can be interpreted as anywhere in the module or system.
Regarding claim 2, Ahlfors discloses the module of claim 1 further comprising a track (rail 710), on which the multi-axis robot moves between the multiple operation units (see Fig. 4 and para [0224] et seq.).
Regarding claim 3, Ahlfors discloses the automated plasmid preparation module of claim 1, wherein, the multi-axis robot comprises a robot arm 705, a holding means (gripper) for a tube and bottle, a capping/decapping means 830 (see para [0246] et seq.), a shaking mechanism 494, one or more liquid dispensing units (pipettors 814; Fig. 14), and sensors (e.g., sensor 426) for receiving signals from the multiple operation units (see para [0163] et seq. and Fig. 16).
Regarding claim 4, Ahlfors discloses the automated plasmid preparation module of claim 1, wherein, the A) culture and lysing unit comprises a sequence of incubators with shaking rack (heater shaker 494) , one or more centrifuges 150, and at least one sterilizer 556, and the B) purification unit comprises one or more vacuum manifolds (filtration stations 492), one or more centrifuges 150, one or more column trays each holding a set number of DNA columns, wherein each DNA column (reads on has an open upper end, an open lower end, a solid phase capable of plasmid DNA capture, and a filter above the solid phase (see para [0315] et seq.)
Regarding claim 5, Ahlfors discloses the automated plasmid preparation module of claim 1 (see remarks with respect to claim 1 above).
Note: as discussed above, process claims 6-18 are indefinite and confusing. It is not clear whether the prior art discloses the steps, however, as best as the claims can be understood, the process steps have been mapped with respect to Ahlfors below.
Regarding claim 6, Ahlfors discloses an automated plasmid preparation process utilizing the automated plasmid preparation system of claim 5, wherein the multi-axis robots (robotic modules) are programmed to operate each of the modules simultaneously (by a control unit, see para [0033] et seq.)
Regarding claim 7, as best understood, Ahlfors discloses an automated plasmid preparation process utilizing the automated plasmid preparation system of claim 5, wherein, the multi-axis robot is programmed to, A) culture and lyse plasmid DNAs, utilizing the culture and lysing unit; and B) purify the plasmid DNAs, utilizing the purification unit (see para [0035] et seq.)
Regarding claim 8, as best understood, Ahlfors discloses the automated plasmid process of claim 7, wherein in the culturing and lysing step, each multi-axis robot is programmed to, a) receive a sequence of incubators each holding a set number of empty culture bottles; b) sequentially for each incubator at a time, filling each of the culture bottles with growth media and inoculating bacteria samples transformed with plasmid; c) upon completion of incubation of one of the sequence of incubators from step b), retrieving one or more of the culture bottles and loading them into the centrifuge; d) upon completion of centrifugation, retrieving one culture bottle from the centrifuge and decanting the supernatant; e) sequentially adding resuspension reagent, lysis reagent, and neutralization reagent into the culture bottle from step d), each addition followed by shaking; f) placing the culture bottle from step e) in the centrifuge; g) repeating steps d)-f) until the centrifuge is full (see para [0015] et seq.)
Regarding claim 9, as best understood, Ahlfors discloses the automated plasmid process of claim 7, wherein, in the B) purifying step, each multi-axis robot is programmed to, h) retrieving equilibrated DNA columns and after step g) and upon completion of centrifugation, sequentially retrieving each of the culture bottles from the centrifuge and moving the supernatant on top of the filter into each of the equilibrated DNA columns; i) placing the DNA columns on top of vacuum manifold which is capable to hold a set of DNA columns; j) applying pressure on the DNA columns and discarding the elute; k) adding wash buffer into the DNA columns, applying pressure on the DNA columns, and discarding the filter and elute; 1) optionally repeating step k) 1 to 3 times; m) for each one of the DNA binding columns, placing one collection bottle underneath thereof; n) adding elution buffer in each of the DNA columns from step m) and applying pressure on the DNA columns to elute aqueous sample in the collection tubes; o) adding isopropyl alcohol in each of the collection tubes from step n) followed by vortexing; p) sequentially placing each of the collection tubes from step o) in the centrifuge until the centrifuge is full; q) upon completion of centrifugation, sequentially retrieving each of the collection tubes from the centrifuge and decanting supernatant; r) sequentially adding water into each of the collection tubes from q) to resuspend sample and removing each of the sample suspensions to each of a series of sample vials (see para [0015] et seq.)
Regarding claim 10, as best understood, Ahlfors discloses the automated plasmid process of claim 8, wherein after step b), each of the sequence of incubators is programmed to sense the completion of inoculation and start incubation or the multi-axis robot is programmed to signaling each of the sequence of incubators to start incubation (see para [0168] et seq.)
Regarding claim 11, as best understood, Ahlfors discloses the automated plasmid preparation process of claim8, wherein, after step c) and after step g), the centrifuge is programmed to sense the completion of loading to start centrifugation or the multi-axis robot is programmed to signal the centrifuge to start centrifugation (see para [0163] et seq.)
Regarding claim 12, as best understood, Ahlfors discloses the automated plasmid preparation process of claim 8, wherein, after step i), if the vacuum manifold is not full, i) if the centrifuge from step d) is not empty, repeating steps d)-i); ii) if the centrifuge from step d) is empty and the one of the sequence of incubators from step c) is not empty, repeating steps c)-i); iii) if the centrifuge from step d) is empty, the one of the sequence of incubators from step c) is empty, and the next incubator in sequence has sent completion signal,
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iv) if the centrifuge from step d) is empty, the one of the sequence of incubators from step c) is empty, and the next incubator in sequence has not sent completion signal, wait until the next incubator in sequence has sent completion signal to repeat steps c)-i) (see para [0163] et seq.)
Regarding claim 13, as best understood, Ahlfors discloses the automated plasmid preparation process of claim 6, wherein, after step r), if there are remaining culture bottles from step c), repeating steps c)-r); and if there are no remaining culture bottles from step c), repeating steps a)-r) or ending process (see para [0163] et seq.)
Regarding claim 14, as best understood, Ahlfors discloses the automated plasmid preparation process of claim 6, wherein, after step h), the multi-axis robot is further programmed to place the culture bottles to recycling station for cleaning and reuse using autoclave (see para [0039] et seq.).
Regarding claim 15, as best understood, Ahlfors discloses the automated plasmid preparation process of claim 6, wherein, after step k) or 1), the multi-axis robot is further programmed to dry the DNA column by blotting and/or vacuum (see para [0196] et seq.)
Regarding claim 16 as best understood, Ahlfors discloses the automated plasmid preparation process of claim 6 wherein, after step n), the multi-axis robot is further programmed to discard the used DNA columns and remove the column tray into waste 156 (see para [0174] et seq.)
Regarding claim 17 as best understood, Ahlfors discloses the automated plasmid preparation process of claim 6 wherein, after step q), the multi-axis robot is further programmed to wash the pellets remaining in the collection tube with 70% ethanol 1 time (see para [0348] et seq.)
Regarding claim 18, as best understood, Ahlfors discloses the automated plasmid process of claim 6, wherein, after step r), the multi-axis robot is further programmed to remove a portion of the sample in each sample vial to microplates for quality control (see para [0184] et seq.)
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure include:
a. Kachel et al., discloses (see the whole document, in particular the description of figure 1, "Layout of the robot" and "Process overview") an automated plasmid preparation module comprising units allowing culture of bacteria, lysis of the transformed bacteria and a purification unit to obtain purified plasmid. According to Kachel, there is comparison of the quality of the obtained plasmid suing then the device and the process described in Kachel and a conventional device. The device described in Kachel comprises a robot which suitable to move the different culture vessels between the different processing units following a plurality of axis (see "The gantry system").
b. Davey et al., (US 2020/0393477) which disclose apparatuses, systems, and methods for processing materials, including biological or chemical materials. A manufacturing module may include a work station configured to perform a process involving equipment capable of use with biological or chemical material, a first transportation segment that is configured to connect and disconnect with a second transportation segment such that when connected, a carrier of the biological or chemical material can be transported from the first transportation segment to the second transportation segment, a pick and place robot configured to move an element between the first transportation segment and the work station; and a movement mechanism configured to allow the work station, the first transportation segment, and the pick and place robot to be moved as a single unit. A system may include a plurality of manufacturing modules that are reconfigurable to a plurality of configurations.
c. Farrelly et al., (US 2007/0184546) which disclose a robotic laboratory automation workcell preferably includes instruments and equipment that are integrated by using conveyor or track elements and a robotic arm. The automation workcell is controlled by a centralized or main controller or processor using specialized control software to automate the proteomics research process. The automated workcell is capable of performing genetic laboratory experiments from start to finish by moving samples or microplates between the instruments for analysis. A goal of the automated workcell is to perform repetitive procedures in an effort to build and maximize the efficiency of a gene(s) of a targeted organism.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to P. Kathryn Wright whose telephone number is (571)272-2374. The examiner can normally be reached on Monday-Thursday 9:30am-7:30pm EST.
Examiner interviews are available via telephone 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.
E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jill A Warden can be reached on 571-272-1267. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P. Kathryn Wright/Primary Examiner, Art Unit 1798