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 “a fan filter unit” as in Claims 8, 12, and 15, 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.
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 limitations are:
“a first pipetting module for transferring a sample” as in Claim 1. “a second pipetting module for deploying a reagent” as in Claim 1.
“the at least two bridging modules for achieving a sequential movement of the nucleic acid extraction kit...” as in Claim 1.
“the first engaging member and the second engaging member are engaged to form a connection channel...” as in Claim 5.
“a first nucleic acid extraction kit conveying module for conveying...” as in Claim 7. “a second nucleic acid extraction kit conveying module for receiving...” as in Claim 10. “a third nucleic acid extraction kit conveying module for receiving...” as in Claim 13.
“a fan filter unit disposed at the first air outlet for maintaining a first airflow...” as in Claims 8, 12, and 15.
“a temperature controlling module for matching with each well of the nucleic acid extraction kit so as to provide a temperature variation...” as in Claim 11.
an assay plate conveying module...the assay plate conveying module conveys the assay plate...” as in Claim 14.
“an assay plate sealing module...the assay plate sealing module performs a film sealing procedure to the assay plate...” as in Claim 14.
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.
“a plurality of...pipettors” as in paras. [0080, 0097] of Applicant’s instant specification filed 09/19/2023...and equivalents thereof.
“The first bridging structure includes a first engaging member, a first opening, a first partition board and a first sliding rail, and the first partition board moves along the first sliding rail to open or close the first opening. The second bridging structure includes a second engaging member, a second opening, a second partition board and a second sliding rail, and the second partition board moves along the second sliding rail to open or close the second opening” as in para. [0013] of Applicant’s instant specification filed 09/19/2023 and the instant drawings filed 09/19/2023 Fig. 7A...and equivalents thereof.
“a protrusion member and a recess member which are correspondingly disposed and capable of engaging with each other” as in para. [0064] of Applicant’s instant specification filed 09/19/2023...and equivalents thereof.
“positioning components 241, belts 242 and sensors” as in paras. [0081, 0089] of Applicant’s instant specification filed 09/19/2023 and the instant drawings filed 09/19/2023 Fig. 7A...and equivalents thereof. -- ***See further the end part of the 35 USC 112(b) section below***
***No corresponding structure is disclosed by Applicant’s specification. -- See the 35 USC 112(b) section below.***
***No corresponding structure is disclosed by Applicant’s specification. -- See the 35 USC 112(b) section below.***
“clamping claws” as in para. [0098] of Applicant’s instant specification filed 09/19/2023 and the instant drawings filed 09/19/2023 Fig. 7A...and equivalents thereof.
***No corresponding structure is disclosed by Applicant’s specification. -- See the 35 USC 112(b) section below.***
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 7-8 and 10-15 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.
Claim limitations “a fan filter unit...for maintaining a first airflow” as in Claims 8, 12, and 15, “a temperature controlling module for matching” as in Claim 11, “nucleic acid extraction kit conveying module conveying/receiving” as in Claims 7, 10, and 13, and “an assay plate sealing module...performs a film sealing procedure” as in Claim 14 invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Regarding the “nucleic acid extraction kit conveying module conveying/receiving” as in Claims 7, 10, and 13, the written description recites “positioning components, belts, and sensors” as corresponding to the claimed “nucleic acid extraction kit conveying module”. However, the “positioning components” are themselves a generic placeholder for which a corresponding structure was not found to be present in Applicant’s written disclosure. As such, the requirements of 35 USC 112(f) requiring a corresponding particular structure remain unmet. Applicant is requested to clarify the structure of the “positioning components” in the written description. Does Applicant merely intend that the conveying module be comprised of belts or belts and sensors?
Claim 12 recites “a first deflector, a second deflector”, Claim 15 recites “a third deflector”, and neither of the claims correlate the first/second/third deflector(s) with any otherwise recited structure or function such that one of ordinary skill in the art would recognize the position or purpose/configuration of the deflector.
Further, Claim 15 depends from Claim 1, which does not recite a first or second deflector. As such, the “third” designation of the reflector of Claim 15 is indefinitely understood. It would appear Applicant may intend Claim 15 to depend from Claim 12.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 7, 9-10, and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (CN 112410204 A – as seen through the machine translation available on Google Patents and attached herein.), hereinafter “Li”.
Regarding Claim 1, Li teaches a combinable nucleic acid pre-processing apparatus (Abstract: “a sample pre-processing unit for transferring the sample to be detected...” – page 11: “The full-automatic nucleic acid detection system provided by the embodiment has the innovative points of modular design of each unit and connection and layout of each unit...”), comprising:
a sample transfer chamber 102 comprising a cover opening and closing module and a first pipetting module for transferring a sample from a sampling tube to a nucleic acid extraction kit (page 7: “the sample pre-treatment unit 102 includes, but is not limited to...an automatic cover opening/closing device (not shown), a multi-channel pipetting device (not shown)...”);
a nucleic acid extraction chamber comprising a nucleic acid extraction module 103 for performing a nucleic acid extraction operation on the sample in the nucleic acid extraction kit so as to obtain a nucleic acid extract (Abstract: “at least one nucleic acid extraction unit for extracting nucleic acid in the sample to be detected on the nucleic acid extraction well plate”);
an assay setup chamber 104 comprising a second pipetting module for deploying a reagent and adding the deployed reagent and the nucleic acid extract into an assay plate (page 7: “the system configuration unit 104 includes, but is not limited to, a multi-channel pipetting device (not shown)...”); and
at least two bridging modules 107 respectively disposed between the sample transfer chamber 102 and the nucleic acid extraction chamber 103 and between the nucleic acid extraction chamber 103 and the assay setup chamber 104 (page 7: “the same type units and/or different types of units can be connected through the transfer units 107” – page 7: “The sample pre-treatment unit 102 is connected to the nucleic acid extraction unit 103 through a transfer unit 107” – page 7: “nucleic acid extraction units 103 are each connected to a system preparation unit 104 via one transfer unit 107”), wherein
the sample transfer chamber 102, the nucleic acid extraction chamber 103 and the assay setup chamber 104 are separated from each other and operated independently (page 9: “the automatic partition 1073 is closed to isolate the sample pretreatment unit 102” – page 8: “The transfer unit 107 includes, but is not limited to...an automatic partition (not shown)” – page 11: “each functional unit can work independently” – See further Fig. 7 showing an example of a partition 1073 of a bridging module 107 having a gripping device.), and
the sample transfer chamber, the nucleic acid extraction chamber and the assay setup chamber are further connected through the at least two bridging modules for achieving a sequential movement of the nucleic acid extraction kit in the sample transfer chamber, the nucleic acid extraction chamber and the assay setup chamber in a duration of nucleic acid pre-processing (See page 10: “The automated nucleic acid detection procedure was as follows: 1. the nucleic acid extraction reagent and the nucleic acid detection reagent are dispensed into the well plate in the consumable preparation unit 101 and then transferred to the corresponding units; 2. the sample tube array is subjected to code scanning and cover opening in the sample pretreatment unit 102, the multichannel pipetting device sucks a sample into the pore plate by using the suction head, and then the sample tube array is closed; 3. the well plate containing the sample is transferred to the nucleic acid extraction unit 103; 4. the magnetic rod and the magnetic sleeve are matched to complete the processes of sample cracking, accounting adsorption, impurity cleaning, nucleic acid elution and the like in sequence; 5. the well plate containing the extracted and purified nucleic acid is transferred to the system preparation unit 104...”),
as in Claim 1.
Regarding Claim 2, the prior art meets the limitations of Claim 1 as discussed above. Further, Li teaches the apparatus discussed above wherein the sample transfer chamber, the nucleic acid extraction chamber and the assay setup chamber individually perform nucleic acid pre-processing procedures of different batches of samples simultaneously (page 11: “each functional unit can work independently, namely, a new round of samples can be put into the unit for processing after each batch of samples in the unit are processed, the whole process of waiting for a batch of samples is not required, the detection time is shortened, and the detection efficiency is improved.” -- Examiner further notes that the recitation “perform nucleic acid pre-processing procedures” is drawn to a broad, generic process recitation. As the claims are drawn to a device, such process recitation is not afforded patentable weight when the prior art device is capable of performing the claimed process. "Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc. – MPEP 2114(II). Herein, the apparatus of Li is commensurately structured as in the instant claims and would be expected to be fully capable of the respective modules performing nucleic acid pre-processing procedures of different batches of samples simultaneously.), as in Claim 2.
Regarding Claim 3, the prior art meets the limitations of Claim 1 as discussed above. Further, Li teaches the apparatus discussed above wherein each bridging module 107 comprises a first bridging structure and a second bridging structure, respectively disposed on adjacent sides of adjacent two chambers (The two sides of the bridging modules 107 which are on opposite sides of the automatic partition.), and by combining the first bridging structure and the second bridging structure, the adjacent two chambers are connected (When the two sides of the bridging modules 107 are connected and the automatic partition opened, the adjacent two chambers are connected. – Note that “a first bridging structure and a second bridging structure” are recited broadly as any generic structure of the bridging module. – Further note that Li provides for two bridging units 107 to be arranged in tandem (page 8) so as to form an overall bridging module with two bridging structures. – Additionally, even if Li were not to provide for adjacently linked transfer units 107, mere duplication of parts has no patentable significance unless a new and unexpected result is produced – see MPEP 2144.04(VI)(B). As such, one skilled in the art would find it obvious to provide additional transfer units if additional sample handling between modules is required as with multiple batches of samples being processed simultaneously.), as in Claim 3.
Regarding Claim 4, the prior art meets the limitations of Claim 3 as discussed above. Further, Li teaches the apparatus discussed above wherein the first bridging structure comprises a first engaging member (page 6: “In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.”), a first opening (Fig. 7: the opening blocked by the automatic partition 1073)), a first partition board (Figs. 6-7: the door of the partition) and a first sliding rail the inserts into which the partition door is inserted (Figs. 6-7), and the first partition board moves along the first sliding rail to open or close the first opening (Figs. 6-7 show the partition as being an upwardly/downwardly slidable along sliding rails flanking the left and right sides.), and
wherein the second bridging structure comprises a second engaging member, a second opening, a second partition board and a second sliding rail, and the second partition board moves along the second sliding rail to open or close the second opening (As discussed above regarding Claim 3, Li provides for plural transfer units 107 arranged in tandem, and one of ordinary skill in the art would further find it obvious to provide additional units for additional processing. Therein, two adjacent units 107 would account for all the structures of engaging member, board, etc. in each of the two bridging structures, which overall when connected form a transfer module.),
as in Claim 4.
Regarding Claim 5, the prior art meets the limitations of Claim 4 as discussed above. Further, Li teaches the apparatus discussed above wherein the first engaging member and the second engaging member are engaged to form a connection channel between the adjacent two chambers for the nucleic acid extraction kit to pass therethrough (The engaging members secure the connection between units, such connection as actuated by an openable partition, thereby forming a passage where a nucleic acid extraction kit may pass therethrough. – See page 6.), the first partition board and the second partition board are located at two opposite ends of the connection channel (Via the connection of two transfer units 107, the partition boards (doors) would be located at two opposite ends of the connection channel as they are located at the ends of the respective units.), and through closing and opening the first opening and the second opening, the adjacent two chambers are mutually separated or connected (See Fig. 7 showing the partition 1073 which, when opened/closed in a situation with two transfer units 107 arranged in tandem, mutually separate or connect the chambers of the two units 107 of the overall bridged module.), as in Claim 5.
Regarding Claim 7, the prior art meets the limitations of Claim 1 as discussed above. Further, Li teaches the apparatus discussed above wherein the sample transfer chamber comprises a first nucleic acid extraction kit conveying module for conveying the nucleic acid extraction kit to the nucleic acid extraction chamber (page 7: “the sample pre-treatment unit 102 includes, but is not limited to...a multi-axis manipulator (not shown)...and the like...”), as in Claim 7.
Regarding Claim 9, the prior art meets the limitations of Claim 1 as discussed above. Further, Li teaches the apparatus discussed above wherein the nucleic acid extraction module 103 comprises a magnetic rod holder, a plurality of magnetic rods mounted on the magnetic rod holder, a magnetic rod sleeve connector holder, and a plurality of magnetic rod sleeve connectors mounted on the magnetic rod sleeve connector holder for performing a magnetic beads-based nucleic acid extraction operation (page 7: “The nucleic acid extraction unit 103 includes, but is not limited to, a magnetic rod array (not shown), a magnetic sleeve array (not shown)...The release, the adsorption, the purification and the desorption of the nucleic acid are realized through the mixing of the magnetic beads and the liquid and the transfer of the magnetic beads.” – Additionally, one of ordinary skill in the art would expect that the magnetic rods and sleeves would require holders so as to be kept in place, even if the holder is merely a surface of the device, as one skilled in the art would not expect such elements to merely be floating in the air.), as in Claim 9.
Regarding Claim 10, the prior art meets the limitations of Claim 1 as discussed above. Further, Li teaches the apparatus discussed above wherein the nucleic acid extraction chamber 103 comprises a second nucleic acid extraction kit conveying module for receiving the nucleic acid extraction kit from the sample transfer chamber and for conveying the nucleic acid extraction kit to the assay setup chamber (page 7: “The nucleic acid extraction unit 103 includes, but is not limited to...a clamping jaw array (not shown)...a mobile well plate station (not shown), a multi-axis motion robot arm (not shown), and the like.”), as in Claim 10.
Regarding Claim 13, the prior art meets the limitations of Claim 1 as discussed above. Further, Li teaches the apparatus discussed above wherein the assay setup chamber comprises a third nucleic acid extraction kit conveying module for receiving the nucleic acid extraction kit from the nucleic acid extraction chamber (page 7: “As shown in fig. 3, the system configuration unit 104 includes, but is not limited to...a gripper array (not shown), a multi-axis robot (not shown)...a mobile well plate station (not shown), and the like.”), as in Claim 13.
Regarding Claim 14, the prior art meets the limitations of Claim 1 as discussed above. Further, Li teaches the apparatus discussed above wherein the assay setup chamber comprises an assay plate conveying module (page 7: “As shown in fig. 3, the system configuration unit 104 includes, but is not limited to...a gripper array (not shown), a multi-axis robot (not shown)...a mobile well plate station (not shown), and the like.”) and an assay plate sealing module (page 7: “As shown in fig. 3, the system configuration unit 104 includes, but is not limited to... an automatic film pasting device 1041...and the like...”), the assay plate conveying module conveys the assay plate with the added reagent and the added nucleic acid extract to the assay plate sealing module, and the assay plate sealing module performs a film sealing procedure to the assay plate (pages 7-8: “In the system preparation unit 104, the nucleic acid amplification reagent from the consumable preparation unit 101 and the nucleic acid from the nucleic acid extraction unit 103 are fully mixed, the loaded and purified nucleic acid enters a nucleic acid amplification reaction system, and the mixing of the nucleic acid and the nucleic acid amplification reagent is completed by automatic film pasting, shaking, centrifugation and the like. In some embodiments, other existing techniques may also be employed to effect the transfer of architectural configuration unit 104.”), as in Claim 14.
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 (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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Li. Li has been discussed above.
Regarding Claim 6, the prior art meets the limitations of Claim 4 as discussed above. Further, Li does not specifically teach the apparatus discussed above wherein the first bridging structure comprises a first protrusion board for forming an inverted trapezoidal shape space around the first opening, the first partition board comprises a second protrusion board in an inverted trapezoidal shape, airtight elements are disposed at a periphery of the second protrusion board, and when the first partition board is moved downwardly, the second protrusion board enters the inverted trapezoidal shape space, and wherein the second bridging structure comprises a third protrusion board for forming an inverted trapezoidal shape space around the second opening, the second partition board comprises a fourth protrusion board in an inverted trapezoidal shape, airtight elements are disposed at a periphery of the fourth protrusion board, and when the second partition board is moved downwardly, the fourth protrusion board enters the inverted trapezoidal shape space, as in Claim 6.
However, Li does teach a pressure-tight seal arranged at the joining portions of each of the modular units (page 8: “The pressure-resistant sealing ring is arranged at the joint of each unit to prevent the exchange of substances among the units.”) so as to ensure substances are not exchanged by the units, thereby alleviating errors due to cross-contamination. While these pressure-tight seals are not particularly taught as being disposed about a periphery of protrusion boards for forming an inverted trapezoidal shape space around the openings, mere change in shape absent evidence to criticality, non-obviousness, or unexpected results associated with the claimed shape is an obvious matter of design choice – see MPEP 2144.04(IV)(B). Herein, one of ordinary skill in the art would have found it an obvious matter of design choice to shape the sealing elements about an inverted-trapezoidal protrusion as such a shaped seal would not perform any differently than the seal of Li, absent evidence of a criticality or unexpected results associated therewith such a trapezoidal shaped protrusion.
Examiner further notes the above claim comprises recitations predicated on conditional process recitations (“when the first partition board is moved downwardly”, “when the second partition board is moved downwardly”) that are both not necessitated by the claim and, as the claims are drawn to a device, such process recitation is not afforded patentable weight. "Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc. – MPEP 2114(II). As such, the requirements of the claim predicated on those conditional processes are not afforded patentable weight herein.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Williams et al. (US 2016/0250640 A1), hereinafter “Williams”. Li has been discussed above.
Regarding Claim 11, the prior art meets the limitations of Claim 1 as discussed above. Further, Li does not specifically teach the apparatus discussed above wherein the nucleic acid extraction chamber comprises a temperature controlling module for matching with each well of the nucleic acid extraction kit so as to provide a temperature variation required during the nucleic acid extraction operation, as in Claim 11.
However, Williams teaches a respective automated nucleic acid extraction workstation comprising a heater assembly which independently heats respective wells/tubes of a multi-well/tube array ([0008]: “a heater assembly configured to independently heat each of the process chambers” – [0015]: “the heater assembly comprises a plurality of independently controllable heater units, each of which is configured to accept and to heat a process chamber”) so as to provide a temperature optimal for nucleic acid extraction, wherein each temperature provided by the independently controllable heater units tailors the amount of heat to the specific sample at hand so as to optimize the extraction process (For example, longer DNA strands generally require higher temperatures to denature (separate) because they have more stabilizing forces across a greater number of base pairs.).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the apparatus of Li wherein the nucleic acid extraction chamber comprises a temperature controlling module for matching with each well of the nucleic acid extraction kit so as to provide a temperature variation required during the nucleic acid extraction operation, such as suggested by Williams, so as to provide a temperature optimal for nucleic acid extraction, wherein each temperature provided by the independently controllable heater units tailors the amount of heat to the specific sample at hand so as to optimize the extraction process, thereby reducing errors related to insufficient heating of a particular sample.
Claims 8, 12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Zhang (CN 104893951 A – as seen through the machine translation available on Google Patents and attached herein.), hereinafter “Zhang”. Li has been discussed above.
Regarding Claims 8, 12, and 15, the prior art meets the limitations of Claim 1 as discussed above. Further, Li does not specifically teach the apparatus discussed above wherein the sample transfer chamber, the nucleic acid extraction chamber, and the assay setup chamber each respectively comprise an air inlet, an air outlet, a deflector and a fan filter unit disposed at the air outlet for maintaining an airflow entering the chamber in a single direction, and wherein the air inlet and the air outlet respectively have high efficiency particulate air filters disposed thereon, as in Claims 8, 12, and 15.
However, Zhang teaches a respective automated genetic analysis workstation comprising an air inlet and an air outlet (page 2: “air of inlet and outlet”), a deflector (Interior walls of the chamber deflecting airflow within the chamber.), and a fan filter unit disposed at the air outlet for maintaining an airflow entering the chamber in a single direction (page 2: “blower fan”), and wherein the air inlet and the air outlet respectively have high efficiency particulate air filters disposed thereon (page 3: “Filter assemblies (3A), for filtering the air of inlet and outlet polymerase chain reaction workstation”), so as to reduce contamination within the device and prevent contaminants from leaving the device.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the apparatus of Li wherein the sample transfer chamber, the nucleic acid extraction chamber, and the assay setup chamber each respectively comprise an air inlet, an air outlet, a deflector and a fan filter unit disposed at the air outlet for maintaining an airflow entering the chamber in a single direction, and wherein the air inlet and the air outlet respectively have high efficiency particulate air filters disposed thereon, such as suggested by Zhang, so as to reduce contamination within the device and prevent contaminants from leaving the device, thereby reducing errors related to contaminated samples, and reducing operator exposure to material within the device.
Further, regarding the Claim 8 recitation “the first airflow does not pass through an area where the nucleic acid extraction kit is placed after passing through an uncovered sampling tube”, the Claim 12 recitation “the second airflow downwardly passes through an area for performing the nucleic acid extraction operation”, and the Claim 15 recitation “the third airflow flows toward an area where the nucleic acid extraction kit is placed”, such recitations are drawn to process recitations (airflow, movement of air within the device). As the claims are drawn to a device, such process recitation is not afforded patentable weight when the prior art device is capable of performing the claimed process. "Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc. – MPEP 2114(II). Herein, the apparatus of Li/Zhang is fully capable of being arranged so as to achieve the above discussed airflow recitations set forth by Claims 8, 12, and 15.
Conclusion
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
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