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 .
Claims 1-20 are currently pending and under examination.
Information Disclosure Statement
The Information Disclosure Statement filed December 08, 2022 has been considered.
Claim Objections
Claim 15 is objected to because of the following informalities:
In claim 15, line 11, “the external external driving device” should read “the external driving device”.
Appropriate correction is required.
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 1-14 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 1 recites the limitation "the sealed cassette", once in lines 2 and once in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-14 depend from claim 1 and therefore are included in this rejection.
Claim 7 recites the limitation "the sum" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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 and 14 are rejected under 35 U.S.C. 102 (a)(1) and (a)(2) as being anticipated by Xie et al. (Machine Translated People’s Republic of China Patent Application Publication CN 209923313 U, published January 10, 2020), cited on the IDS filed December 08, 2022.
Regarding claims 1, Xie teaches a library preparation cassette (Title and abstract). Xie teaches a pipette (injection unit) and a mixing reagent tray (reagent/receiving grooves) arranged within the sealed cassette (Abstract and Page 3, Last Three Paragraphs and Page 4, First Two Paragraphs). Xie teaches the pipette is at least vertically movably arranged within the sealed cassette (Page 7, First Paragraph). Xie teaches the mixing reagent tray is a circular tray and is rotatable clockwise or counterclockwise at least about a geometric center thereof as an axis (Abstract and Page 5, Last Five Paragraphs). Xie teaches the mixing reagent tray is provided with a plurality of reagent wells, which are configured to at least include two different well pitches (Page 4, Second and Fourth Paragraph and Page 8, First Paragraph). Xie teaches a downward projection relative straight-line distance between the pipette and the geometric center of the mixing reagent tray is changeable by horizontal movement of the mixing reagent tray, so that the pipette corresponds vertically to any reagent well on the mixing reagent tray as selected and performs a liquid drawing or liquid injection operation on the reagent well (e.g., pipette/injection unit moves up/down and the reagent grooves rotate horizontally, Abstract, Page 2, Last Two Paragraph, Page 5, Second Paragraph—Page 6, First Paragraph and Page 7, First Paragraph). Xie teaches the well pitches comprise a straight-line distance from the geometric center of the mixing reagent tray to a geometric center of the reagent well (Figs. 3 and 8).
Regarding claims 14, Xie teaches the cassette further comprises a mixing reagent tray base, a pipette pump assembly and a cassette housing (Abstract, Page 3, Tenth Paragraph, Page 6, Last Paragraph and Figs. 1-8). Xie teaches the mixing reagent tray base comprises a bottom seat and a top cover (Abstract, Page 4, Fifth Paragraph and Page 8, Fourth Paragraph). Xie teaches the mixing reagent tray is placed within the mixing reagent tray base and is provided with vertical movement limits and horizontal plane movement limits by the bottom seat and the top cover(Page 7, Third Paragraph and Figs. 1-5 and 8). Xie teaches the pipette pump assembly provides a liquid drawing or liquid injection driving force for the pipette (Page 6, Last Paragraph). Xie teaches the cassette housing is independently provided with a hot lid capable of heating and thermally insulating specified reagent wells and a sampling through hole capable of opening/sealing and closing specified reagent wells (Page 8, First and Fourth Paragraph and Page 4, Fifth Paragraph).
Xie teaches each and every claim limitation of claims 1 and 14 and therefore Matsumoto anticipates claims 1 and 14.
Claims 1-2, 8-10 and 14-20 are rejected under 35 U.S.C. 102 (a)(1) and (a)(2) as being anticipated by Matsumoto et al. (U.S. Patent Application Publication US 2004/0265173 A1, published December 30, 2004).
Regarding claim 1, Matsumoto teaches a three-degree-of-freedom library preparation cassette, comprising a pipette and a mixing reagent tray arranged within the sealed cassette, wherein the pipette is at least vertically movably arranged within the sealed cassette (Abstract, Page 5, [0065] and Figs. 1-5). Matsumoto teaches the mixing reagent tray is a circular tray and is rotatable clockwise or counterclockwise at least about a geometric center thereof as an axis (Page 2, [0016] and Page 3, [0042]). Matsumoto teaches the mixing reagent tray is provided with a plurality of reagent wells, which are configured to at least include two different well pitches (Fig. 1). Matsumoto teaches a downward projection relative straight-line distance between the pipette and the geometric center of the mixing reagent tray is changeable by horizontal movement of the pipette or the mixing reagent tray, so that the pipette corresponds vertically to any reagent well on the mixing reagent tray as selected and performs a liquid drawing or liquid injection operation on the reagent well (Abstract , Page 5, [0065], and Page 6, [0071]-[0072]). Matsumoto teaches the well pitches comprise a straight-line distance from the geometric center of the mixing reagent tray to a geometric center of the reagent well, and a straight-line distance from the geometric center of the mixing reagent tray to a position on the reagent well corresponding to the liquid drawing or liquid injection operation by the pipette (Abstract, Page 5, [0065], Page 6, [0071]-[0072] and Figs. 1-5).
Regarding claims 2, Matsumoto teaches the pipette moves horizontally from the geometric center of the mixing reagent tray to an edge of the mixing reagent tray along any straight line passing through the geometric center of the mixing reagent tray (Abstract , Page 5, [0065], Page 6, [0071]-[0072] and Figs. 1-5).
Regarding claim 8, Matsumoto teaches the mixing reagent tray is further integrally formed with a driven gear, and an external driving device drives, through gear engaged connection, the driven gear to rotate and cause the mixing reagent tray to rotate (Page 3, [0043]).
Regarding claim 9, Matsumoto teaches the driven gear does not occupy a top reagent well region of the mixing reagent tray (Page 3, [0043]).
Regarding claim 10, Matsumoto teaches the mixing reagent tray is further provided with a limit strip, which is controlled to lock/release the rotation of the mixing reagent tray (e.g., an automated analyzer and sensor that detects pre-determined home/stop position and then stops rotation of the mixing reagent tray locking it in place, Page 2, [0025]-[0026] and Page 8, [106]).
Regarding claim 14, Matsumoto teaches the cassette further comprises a mixing reagent tray base, a pipette pump assembly and a cassette housing (Abstract, Page 4, [0054] and Figs. 1-5). Matsumoto teaches the mixing reagent tray base comprises a bottom seat and a top cover (Page 5, [0062], Page 6-7, [0078] and Page 4, [0047]). Matsumoto teaches the mixing reagent tray is placed within the mixing reagent tray base and is provided with vertical movement limits and horizontal plane movement limits by the bottom seat and the top cover (Page 2, [0015], Page 5, [0062], Page 6-7, [0078], Page 4, [0047] and Figs. 1-4 and 6). Matsumoto teaches the pipette pump assembly provides a liquid drawing or liquid injection driving force for the pipette (Page 1, [0008] and [0099] and Page 5, [0065]). Matsumoto teaches the cassette housing is independently provided with a hot lid capable of heating and thermally insulating specified reagent wells and a sampling through hole capable of opening/sealing and closing specified reagent wells (Page 1, [0008], Page 3, [0042], Page 4, [0047], Page 6-7, [0078] and Page 5, [0062]-[0064]).
Regarding claims 15, Matsumoto teaches a method of using a three-degree-of-freedom library preparation cassette (Abstract, Page 4, [0054], Page 5, [0065], Page 6, [0071]-[0072] and Figs. 1-5). Matsumoto teaches a mixing reagent tray containing required reagents sealed therein, into a cassette housing by means of a mixing reagent tray base to form a complete cassette (Page 2, [0016] and Page 4, [0054]). Matsumoto teaches connecting the complete cassette installed with the mixing reagent tray to an external driving device, and using the external driving device to operate the mixing reagent tray to rotate, and enable horizontal movement of the pipette and vertical movement of the pipette, to accomplish a library preparation process (Page 5, [0065] and Fig. 4). Matsumoto teaches reaction product drawing and waste disposal: disconnecting the used cassette from the external driving device, and drawing reaction products from reaction reagent wells, and properly disposing the remaining part as a waste (Page 1, [0005], Page 2, [0016]-[0017], Page 7, [0087] and Pages 7-8, [0092]).
Regarding claims 16, Matsumoto teaches mounting a detached separately stored magnetic bead reagent well loaded with magnetic beads onto the mixing reagent tray (e.g., removable reagent cups specifically used for magnetic beads, Page 1, [0009]-[0010], Page 2 [0016] and Page 7, [0082].
Regarding claims 17, Matsumoto teaches locking the mixing reagent tray in an initial position of preparation by using a limit strip (e.g., an automated analyzer and sensor that detects pre-determined home/stop position and then stops rotation of the mixing reagent tray locking it in place, Page 2, [0025]-[0026] and Page 8, [106]).
Regarding claims 18, Matsumoto teaches releasing the mixing reagent tray to rotate by pushing the limit strip by the external driving device (e.g., an automated analyzer and sensor that detects pre-determined home/stop position to stop rotation, and restarts rotation using external driver motor PM6, Page 5, [0065], Page 6, [0076], Page 8 [0100]-[0101] and [0106]).
Regarding claims 19, Matsumoto teaches heating and thermally insulating the reaction reagent wells provided in the mixing reagent tray by using a hot lid (Page 3, [0042] and Page 4, [0047]).
Regarding claims 20, Matsumoto teaches drawing the preparation products from the reaction reagent wells through a sampling through hole (Abstract and Page 5, [0064]-[0065]).
Matsumoto teaches each and every claim limitation of claims 1-2, 8-10 and 14-20 and therefore Matsumoto anticipates claims 1-2, 8-10 and 14-20.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 3-7 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Matsumoto et al. (U.S. Patent Application Publication US 2004/0265173 A1, published December 30, 2004) as applied to claims 1-2, 8-10 and 14-20 above, in view of Xie et al. (Machine Translated People’s Republic of China Patent Application Publication CN 209923313 U, published January 10, 2020), cited on the IDS filed December 08, 2022.
Regarding claims 3, Matsumoto teaches the mixing reagent tray is provided with a plurality of reagent wells arranged annularly successively in concentric circles with at least two different well pitches (Figs. 1-6). Matsumoto teaches the number of different reagent cups can be increased (Page 2, [0013]). Matsumoto teaches the reaction containers are provided at predetermined spacing around the periphery of the rotor main body (e.g., the reagent wells are designed by user’s choice, Page 2, [0019]).
Regarding claims 4, Matsumoto teaches an inner circle reagent well group comprises at least one magnetic bead reagent well, which is detachable from the mixing reagent tray (Page 1, [0009]-[0010] and Page 2, [0016]). Matsumoto teaches reagent wells (Abstract and Figs. 1-6). Matsumoto teaches the outer circle reagent well group at least comprises a plurality of reaction reagent wells, a plurality of library capture reagent wells, one cleaning reagent well, and one waste reagent well (Abstract, Page 2, [0017]-[0018], Page 7, [0087], Page 8, [0092] and Figs. 1-6).
Regarding claims 5, Matsumoto teaches the magnetic bead reagent well, the reagent wells, the cleaning reagent well and the waste reagent well have different volumes and/or shapes (Figs. 1-6).
Regarding claims 6, Matsumoto teaches at least one of the plurality of reaction reagent wells is detachable from the mixing reagent tray (Page 2, [0016]).
Regarding claims 11, Matsumoto teaches the pipette is connected to a rotating shaft and a screw, respectively, ends of which extend out of the sealed cassette and the screw rotates and drives the pipette to move horizontally (Abstract, Page 5, [0065] and [0068] and Fig. 4). Matsumoto teaches the rotating shaft rotates and causes a vertical driving gear provided on the rotating shaft to rotate and drive a pipette head component of the pipette to move vertically (Abstract, Page 5, [0065] and [0068] and Fig. 4).
Regarding claims 12 and 13, Matsumoto teaches the rotating shaft is in clearance fit with the vertical driving gear provided on the rotating shaft, and the vertical driving gear is capable of freely moving axially along the rotating shaft (Abstract, Page 5, [0065] and [0068] and Fig. 4). Matsumoto teaches the rotating shaft and the vertical driving gear are in circumferential limit connection having at least one tangential surface to transmit torque (Abstract, Page 5, [0065] and [0068] and Fig. 4).
Matsumoto does not teach or suggest a plurality of reagent wells arranged annularly successively in concentric circles with three different well pitches from inside to outside, forming three groups consisting of a plurality of reagent wells arranged successively along the concentric circles of different well pitches, respectively, namely, an inner circle reagent well group, a middle circle reagent well group and an outer circle reagent well group. Matsumoto does not teach or suggest a middle circle reagent well group comprises a plurality of library construction reagent wells. Matsumoto does not explicitly teach or suggest the ends of the rotating shaft and the screw extending out of the sealed cassette are each provided with both an inner spline and an outer spline and the external driving device transmits torque to the rotating shaft and the screw by combined action of an outer spline and an inner spline corresponding to the inner spline and the outer spline.
Xie teaches a library preparation cassette (Title and abstract). Xie teaches a pipette (injection unit) and a mixing reagent tray (reagent/receiving grooves) arranged within the sealed cassette (Abstract and Page 3, Last Three Paragraphs and Page 4, First Two Paragraphs). Xie teaches the pipette is at least vertically movably arranged within the sealed cassette (Page 7, First Paragraph). Xie teaches the mixing reagent tray is a circular tray and is rotatable clockwise or counterclockwise at least about a geometric center thereof as an axis (Abstract and Page 5, Last Five Paragraphs). Xie teaches the mixing reagent tray is provided with a plurality of reagent wells, which are configured to at least include two different well pitches (Page 4, Second and Fourth Paragraph and Page 8, First Paragraph). Xie teaches a downward projection relative straight-line distance between the pipette and the geometric center of the mixing reagent tray is changeable by horizontal movement of the mixing reagent tray, so that the pipette corresponds vertically to any reagent well on the mixing reagent tray as selected and performs a liquid drawing or liquid injection operation on the reagent well (e.g., pipette/injection unit moves up/down and the reagent grooves rotate horizontally, Abstract, Page 2, Last Two Paragraph, Page 5, Second Paragraph—Page 6, First Paragraph and Page 7, First Paragraph). Xie teaches the well pitches comprise a straight-line distance from the geometric center of the mixing reagent tray to a geometric center of the reagent well (Figs. 3 and 8). Xie teaches the mixing reagent tray is provided with a plurality of reagent wells arranged annularly successively in concentric circles with three different well pitches from inside to outside, forming three groups consisting of a plurality of reagent wells arranged successively along the concentric circles of different well pitches, respectively, namely, an inner circle reagent well group, a middle circle reagent well group and an outer circle reagent well group (Fig. 8). Regarding claim 4, Xie teaches detachable reagent well (Page 3, Second to Last Paragraph). Xie teaches the middle circle reagent well group comprises a plurality of library construction wells (Page 7, Third Paragraph). Xie teaches the outer circle reagent well group at least comprises a plurality of reaction reagent wells, a plurality of library capture reagent wells (Page 7, Third and Last Paragraph and Fig. 8). Xie teaches the library construction reagent wells, reaction reagent well, the library capture reagent wells, the cleaning reagent well and the waste reagent well have different volumes and/or shapes (Figs. 3 and 8). Xie teaches at least one of the plurality of reaction reagent wells is detachable from the mixing reagent tray (Page 3, Second to Last Paragraph). Xie teaches the mixing reagent tray is further integrally formed with a driven gear, and an external driving device drives, through gear engaged connection, the driven gear to rotate and cause the mixing reagent tray to rotate (Abstract, Page 2, Second to Last Paragraph, Page 5, Fifth Paragraph and Page 7, Sixth Paragraph). Xie teaches the driven gear does not occupy a top reagent well region of the mixing reagent tray (Abstract, Page 2, Second to Last Paragraph, Page 5, Fifth Paragraph and Page 7, Sixth Paragraph). Xie teaches the ends of the rotating shaft and the screw extending out of the sealed cassette are each provided with both an inner spline and an outer spline and the external driving device transmits torque to the rotating shaft and the screw by combined action of an outer spline and an inner spline corresponding to the inner spline and the outer spline (Figs. 4 and 5). Xie teaches using the disclosed library preparation box greatly improves the operating efficiency and reduces the error occurrence probability as well as provides for the automation of gene sequencing library preparation (Abstract, Page 4, Sixth Paragraph and Page 6, First Paragraph).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have modified the invention of Matsumoto with the teachings of Xie to include a middle circle reagent well group comprising a plurality of library construction reagent wells. This would allow for improved operating efficiency and reduced error occurrence probability as well as provides for the automation of gene sequencing library preparation as taught by Xie (Abstract, Page 4, Sixth Paragraph and Page 6, First Paragraph).
Additionally, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to design the reagent wells to cover 90% or more of the reagent tray because Matsumoto teaches that the reagent wells may be designed to user’s choice and that the amount of reagent wells may be increased. Therefore, it would have been obvious that any user could adjust the spacing and/or amount of reagent wells to any desired spacing and amount of coverage (e.g., 90% or more) that would allow for analysis of a sample.
Additionally, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to combine the middle group of library construction reagent wells of Xie with the reagent wells of Matsumoto with reasonable success because Matsumoto teaches the number of different reagent cups can be increased (Page 2, [0013]). Therefore, the regent well design of Xie is well suited for the reagent well cassette design of Matsumoto.
Conclusion
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/JESSICA D PARISI/ Examiner, Art Unit 1684
/HEATHER CALAMITA/ Supervisory Patent Examiner, Art Unit 1684