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 .
Status of the Claims
Claims 1, 7-8, 11, and 14-18 have been amended. Claim 10 has been canceled. Claims 1-9 and 11-18 are currently examined herein.
Status of the Rejection
All claim objection, U.S.C. § 101, and U.S.C. § 103 rejections are withdrawn in view of Applicant’s amendments.
New grounds of claim objection, U.S.C § 112b, and U.S.C. § 103 rejections are necessitated by Applicant’s amendments.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, please amend “wherein the calculating the preparation amount of the reagent to be a round number includes calculating a minimum value that is an integer multiple of the specific value and that is greater than the required amount of the reagent” to “wherein the calculating the preparation amount of the reagent to be [[a]] the round number includes calculating [[a]] the minimum value that is [[an]] the integer multiple of the specific value and that is greater than the required amount of the reagent”
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 1-9 and 11-18 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.
Regarding Claim 1, the limitation “the minimum value” in line 14 lacks antecedent basis. Claims 2-9 and 11-17 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 1.
Regarding Claim 18, the limitation “the minimum value” in line 20 lacks antecedent basis.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over MultiNA (Microchip Electrophoresis System for DNA/RNA Analysis MCE-202 MultiNA Instruction Manual, 2013).
Regarding Claim 1, MultiNA teaches a display method for displaying an amount of a reagent to be prepared by a user in an electrophoretic apparatus (window displays volume of separation buffer, marker solution, and chip cleaning solution required for analysis of unanalyzed samples in the analysis schedule [first para. page 77]; also see window display on page 77), the display method comprising:
receiving, via an input device (keyboard [box in options Section 4.5.2 page 108]), information of an electrophoresis process to be performed by the electrophoresis apparatus (amount of reagent is determined by the amount required for the unanalyzed samples in analysis schedule, which is calculated from sample sheet input by user [first para. page 77]);
calculating, by a processor (computer in communication with electrophoresis instrument includes a processor [PC Requirement, page 5]), a required amount of the reagent for the electrophoresis process based on the information received via the input device (amount of reagent is calculated based on analysis schedule input by the user [first para. page 77]);
calculating, by the processor, a preparation amount of the reagent based on the required amount of the reagent (amount calculated is the amount required for the unanalyzed samples [first para. page 77]), and the preparation amount of the reagent being a round number (amount of reagent is displayed on computer window as illustrated in window display on page 77 is a round number); and
displaying the preparation amount of the reagent (amount of reagent is displayed on computer window as illustrated in window display on page 77),
wherein the processor is configured to read a specific value stored in a memory (specific value is the volume of sample needed for an individual run in the sample sheet that is saved on the computer [Step 8 in Section 4.1.6 on page 77]), and calculate the preparation amount of the reagent to a value that is a minimum value greater than the required amount of the reagent (Required amount displayed includes excess volumes and is thus greater than required amount for runs [see text and end of Section 4.1.6 Reagent Information, page 77]); and
wherein the calculating the preparation amount of the reagent to be the round number (as illustrated in Step 8 in Reagent Display, reagent is a round number [page 77]) includes calculating the minimum value that is greater than the required amount of the reagent (required amount listed is greater than the required amount of reagent for runs [Section 4.1.6 on page 77]).
Multi-NA does not explicitly teach for all embodiments wherein the processor calculates the preparation amount of the reagent to a value that is an integer multiple of the specific value; and
wherein the calculating the preparation amount of the reagent to be the round number includes calculating the minimum value that is an integer multiple of the specific value.
However, in some embodiments, Multi-NA teaches wherein the processor calculates the preparation amount of the reagent to a value that is an integer multiple of the specific value (volumes of reagents are based on integer multiple of number of sample runs [Step 8 in Section 4.1.6 in page 77]; as an example, calculations for extra sample stand on page 48 includes an integer times the number of analysis +1, which is an integer of the number of analysis).
It would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the processor of Multi-NA to be configured to calculate the preparation amount of the reagent to a value that is an integer multiple of the specific value, as taught by Multi-NA, as the amount of reagent required is based on the number of sample runs in a sample sheet to be tested (Multi-NA, both Tables on page 48). In addition, as Multi-NA teaches both the preparation amount of the reagent to be a round number that is greater than the required reagent for a sample sheet run, and teaches calculating a value that is an integer multiple of the specific value, it would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the processor of Multi-NA to be configured to select a preparation amount of the reagent wherein the calculating the preparation amount of the reagent to be a round number includes calculating a minimum value that is an integer multiple of the specific value, as the amount of preparation reagent required by the instrument to perform an electrophoresis run ranges from the preparation reagent required for the electrophoresis runs in a sample sheet plus any addition reagent volume necessary for the instrument to function (such as reagent amount needed for conditioning and fill checks, see Section 4.1.6 of Multi-NA page 77) to the maximum amount of reagent the instrument can hold. Choosing from a finite number of identified, predictable solutions, with a reasonable expectation for success, is likely to be obvious to a person if ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143 (I)(E)).
Regarding Claim 2, MultiNA teaches the display method according to claim 1.
MultiNA teaches measuring an amount of the reagent accommodated in the electrophoresis apparatus (electrophoresis system measures the amount of reagents remaining in instrument as No. 8 as calculated from sample sheet [page 77]); and
displaying the measured amount of the reagent (amount of reagent is display in window, shown as No. 8 in manual [page 77]).
Regarding Claim 3, MultiNA teaches the display method according to claim 2.
MultiNA teaches further comprising notifying a warning when the measured amount of the reagent is less than the required amount of the reagent (displayed color indicates status of reagent; a color of red indicates insufficient reagent [page 77]).
Regarding Claim 4, MultiNA teaches the display method according to claim 2.
MultiNA teaches the reagent includes a first separation buffer (first separation buffer can be DNA-500, see separation buffers in reagent holder on bottom left of page 11) and a second separation buffer (second separation buffer can be DNA-1000 in reagent holder [page 11]) different in type from the first separation buffer (DNA-500 and DNA-1000 are different types of separation buffers [page 11]), and
the displaying the amount of the reagent accommodated in the electrophoresis apparatus includes displaying an amount of the second separation buffer accommodated in the electrophoresis apparatus in a display manner different from a display manner for an amount of the first separation buffer accommodated in the electrophoresis apparatus (as illustrated in display window on page 77, each separation buffer is displayed in a different color).
Regarding Claim 5, MultiNA teaches the display method according to claim 2.
MultiNA teaches the reagent includes a first marker solution (first marker solution can be the marker solution associated with DNA-500, as illustrated in reagent holder stand on page 11) and a second marker solution (second marker solution can be the marker solution associated with RNA/DNA-12000, as illustrated in reagent holder stand on page 11) different in type from the first marker solution (markers associated with their respective separation buffers are different [reagents and apparatus used table, page 47 and first para. page 20]), and
the displaying the amount of the reagent accommodated in the electrophoresis apparatus includes displaying an amount of the second marker solution accommodated in the electrophoresis apparatus in a display manner different from a display manner for an amount of the first marker solution accommodated in the electrophoresis apparatus (as illustrated in display window on page 77, each marker solution is displayed in a different color).
Regarding Claim 6, MultiNA teaches the display method according to claim 2.
MultiNA teaches further comprising displaying the required amount of the reagent when the measured amount of reagent is equal to or more than the required amount of reagent (as illustrated in the display window on page 77, required amount is displayed when the remaining amount is higher than the required amount).
Regarding Claim 7, MultiNA teaches the display method according to claim 6, wherein
the reagent accommodated in the electrophoresis apparatus includes a first separation buffer (first separation buffer can be DNA-500, see separation buffers in reagent holder on bottom left of page 11) and a second separation buffer (second separation buffer can be DNA-1000 in reagent holder [page 11]) different in type from the first separation buffer (DNA-500 and DNA-1000 are different types of separation buffers [page 11]), and
wherein the displaying the amount of the reagent accommodated in the electrophoresis apparatus includes displaying an amount of the second separation buffer accommodated in the electrophoresis apparatus from a display manner different from a display manner for an amount of the first separation buffer accommodated in the electrophoresis apparatus (as illustrated in display window on page 77, each separation buffer is displayed in a different color); and
displaying a required amount of the second separation buffer in a display manner different from a display manner for a required amount of the first separation buffer (as illustrated in display window on page 77, each required separation buffer is displayed with a different color).
Regarding Claim 8, MultiNA teaches the display method according to claim 6.
MultiNA teaches the reagent accommodated in the electrophoresis apparatus includes a first marker solution (first marker solution can be the marker solution associated with DNA-500, as illustrated in reagent holder stand on page 11) and a second marker solution (second marker solution can be the marker solution associated with RNA/DNA-12000, as illustrated in reagent holder stand on page 11) different in type from the first marker solution (markers associated with their respective separation buffers are different [reagents and apparatus used table, page 47 and first para. page 20]), and
wherein the displaying the amount of the reagent accommodated in the electrophoresis apparatus includes displaying an amount of the second marker solution accommodated in the electrophoresis apparatus in a display manner different from a display manner for an amount of the first marker solution accommodated in the electrophoresis apparatus (as illustrated in display window on page 77, each marker solution is displayed in a different color); and
displaying a required amount of the second marker solution in a display manner different from a display manner for a required amount of the first marker solution (as illustrated in display window on page 77, each required separation buffer is displayed with a different color).
Regarding Claim 9, MultiNA teaches the display method according to claim 1, wherein the reagent includes at least one of a separation buffer (separation buffer can be DNA-500 in reagent holder [page 11]) and a marker solution (marker solution can be marker solution associated with separation buffer DNA-500 [page 11]).
Regarding Claim 11, MultiNA teaches the display method according to claim 1.
MultiNA teaches the reagent includes a separation buffer (separation buffer can be DNA-500 in reagent holder [page 11]) and a marker solution (marker solution can be marker solution associated with separation buffer DNA-500 [page 11]).,
the specific value includes a first specific value for the separation buffer (for DNA-500 kit, first specific value for each individual run corresponds to the volume of buffer for 1 analysis which is (1,000/24) ≈ 42 µL [see entire section of 11.1 Preparation of the DNA-500 Kit, page 288]) and a second specific value for the marker solution (for DNA-500 kit, second specific value is volume for 1 analysis of marker solution is (11/4) µL ≈ 2.8 µL [see entire section of 11.1 Preparation of the DNA-500 Kit, page 288]) and
the second specific value is less than the first specific value (as outlined above, the second specific value for the maker solution is less than the first specific value for the buffer solution).
Regarding Claim 12, MultiNA teaches the display method according to claim 1.
MultiNA teaches the reagent accommodated in the electrophoresis apparatus includes a first separation buffer (first separation buffer can be DNA-500, see separation buffers in reagent holder on bottom left of page 11) and a second separation buffer (second separation buffer can be DNA-1000 in reagent holder [page 11]) different in type from the first separation buffer (DNA-500 and DNA-1000 are different types of separation buffers [page 11]), and
the displaying the preparation amount of the reagent includes displaying a preparation amount of the second separation buffer in a display manner different from a display manner for a preparation amount of the first separation buffer (as illustrated in display window on page 77, each separation buffer is displayed in a different color).
Regarding Claim 13, MultiNA teaches the display method according to claim 1.
MultiNA teaches the reagent accommodated in the electrophoresis apparatus includes a first marker solution (first marker solution can be the marker solution associated with DNA-500, as illustrated in reagent holder stand on page 11) and a second marker solution (second marker solution can be the marker solution associated with RNA/DNA-12000, as illustrated in reagent holder stand on page 11) different in type from the first marker solution (markers associated with their respective separation buffers are different [reagents and apparatus used table, page 47 and first para. page 20]), and
the displaying the preparation amount of the reagent includes displaying a preparation amount of the second marker solution in a display manner different from a display manner for a preparation amount of the first marker buffer (as illustrated in display window on page 77, each separation buffer is displayed in a different color).
Regarding Claim 14, MultiNA teaches the display method according to claim 1.
MultiNA teaches wherein the reagent includes a separation buffer (separation buffer for DNA separations [Table on bottom of page 45]), and
wherein the separation buffer is obtained by mixing a pre-preparation separation buffer and a fluorescent dye solution at a specific ratio (diluted dye solution and TE buffer are mixed at a ratio of 199:1 [step 3, page 45]),
the display method further comprising:
calculating, based on the specific ratio, a mixed amount of the pre-preparation separation buffer and a mixed amount of the fluorescent dye solution in the preparation amount of the reagent (total amount of separation buffer and diluted dye solution calculated based on number of analyses using the specific ratio of separation buffer and diluted dye solution of 199:1 [see Table in step 3, page 45]); and
displaying the mixed amount of the pre-preparation separation buffer (required amount of separation buffer can be displayed [see display window No. 8, page 77]).
MultiNA is silent on displaying the mixed amount of the fluorescent dye solution.
However, as MultiNA teaches the calculation method to prepare the mixed amount of fluorescent dye solution and also displays other required amounts of reagents including separation buffer and marker solution, it would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the display window of MultiNA to include displaying the mixed amount of the fluorescent dye solution. Applying a known technique to a known device (method or product) ready for improvement to yield predictable results is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143(I)(D)).
Regarding Claim 15, MultiNA teaches the display method according to claim 1, wherein
the reagent includes a separation buffer (separation buffer can be DNA-500 in reagent holder [page 11]) and a marker solution (marker solution can be marker solution associated with separation buffer DNA-500 [page 11]), and
wherein the information includes at least one of
a type of separation buffer (type of separation buffer is selected, see step 4 to configure conditions [bottom table, page 36]).
Regarding Claim 16, MultiNA teaches the display method according to claim 1, wherein
the reagent includes a separation buffer (separation buffer can be DNA-500 in reagent holder [page 11]), a marker solution (marker solution can be marker solution associated with separation buffer DNA-500 [page 11]), and a cleaning liquid (chip cleaning solution [Section 3.5.5, page 50]), and
wherein the information includes at least one of:
a type of separation buffer (type of separation buffer is selected, see step 4 to configure conditions [bottom table, page 36]).
Regarding Claim 17, MultiNA teaches a non-transitory computer readable medium with a program is recorded (MultiNA Control Software on 40 GB HDD [PC Requirement Table, page 5 and Step 4, page 23), thereon, that when executed by a processor of a controller (CPU, such as Intel Pentium III processor or equivalent [PC Requirement Table, page 5]), causes the controller to perform the display method of claim 1 (computer screen displays required amounts of separation buffer and marker solution using the MultiNA Control Software [display window top of page 77]).
Regarding Claim 18, MultiNA teaches an electrophoresis system (MCE-202 MultiNA microchip electrophoresis system [first sentence page i]) comprising: an electrophoresis mechanism (MultiNA electrophoresis system, see photos of system on page 8);
a control device that controls the electrophoresis mechanism (PC which includes a CPU, Memory, HDD, and Display [page 5], the PC controls the MultiNA instrument [see generally Section 3.2 Startup, pages 22-25]); and
a display device (computer screen display [PC requirement, page 5]), wherein
the control device includes a calculation unit (CPU [PC requirement, page 5]), and an interface (computer screen displays MutliNA Control Software interface, see example screen on page 14]) configured to receive electrophoresis process information (computer screen receives sample run information for each sample [see MultiNA Control Software screenshot on page 14]),
the calculation unit is configured to calculate a required amount of a reagent for the electrophoresis process based on the information acquired via the interface (amount of reagent is calculated based on analysis schedule [first para. page 77]);
wherein the calculation unit is configured to read a specific value stored in a memory (specific value is the volume of sample based on an individual run in the sample sheet that is saved on the computer [Step 8 in Section 4.1.6 on page 77]),
wherein the calculation unit is configured to calculate a preparation amount of the reagent based on the calculated required amount of the reagent (required reagent amount is based on number of sample runs [Step 8 of Section 4.1.6 Reagent Information, page 77]), the calculated preparation amount of the reagent that is more than the calculated required amount of the reagent (required reagent amount is based on number of sample runs and includes excess volume for other steps like pretreatment [Step 8 of Section 4.1.6 Reagent Information, page 77]), and is a minimum value greater than the required amount of reagent (required reagent amount is greater than reagent amount necessary for total sample runs [Step 8 of Section 4.1.6 Reagent Information, page 77]);
wherein the display device displays the calculated preparation amount of the reagent (calculated preparation amount is displayed for separation buffer and marker solution [Section 4.1.6 Reagent Information screenshot, page 77).
Multi-NA does not explicitly teach for all embodiments wherein the calculation unit calculates the calculated preparation amount being a round number that is an integer multiple of the specific value.
However, in some embodiments, Multi-NA teaches wherein the processor calculates the preparation amount of the reagent to a value that is an integer multiple of the specific value (volumes of reagents are based on integer multiple of number of sample runs [Step 8 in Section 4.1.6 in page 77]; in addition, example for extra sample stand includes an integer times the number of analysis +1, which is an integer of the number of analysis).
It would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the calculation unit of Multi-NA to calculate the calculated preparation being an integer multiple of the specific value, as taught by Multi-NA, as the amount of reagent required is based on the number of sample runs in a sample sheet to be tested (Multi-NA, both Tables on page 48). In addition, as Multi-NA teaches both the required amount of prepared reagent to be a round number that is greater than the required reagent for a sample sheet run, and teaches calculating a value that is an integer multiple of the specific value, it would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the calculation unit to select a calculated preparation amount of reagent wherein the calculating the preparation amount of the reagent to be a round number includes calculating a minimum value that is an integer multiple of the specific value, as the amount of preparation reagent required by the instrument would range from the preparation reagent required by the electrophoresis run plus any additional reagent volume necessary for the instrument to function (such as reagent amount needed for conditioning and fill checks, see Section 4.1.6 of Multi-NA page 77) to the maximum amount of reagent the instrument can hold. Choosing from a finite number of identified, predictable solutions, with a reasonable expectation for success, is likely to be obvious to a person if ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143 (I)(E)).
Response to Arguments
Applicant's arguments, see Remarks pgs. 8-18, filed 04/17/2026, with respect to the 35 U.S.C 101 and 35 U.S.C 103 rejections and amended claims have been fully considered.
Applicant’s Argument #1:
Applicant traverses the prior art 35 U.S.C 101 on pages 11-17 by reciting that the calculating steps are performed by a processor to add hardware limitations to independent claims 1 and 18. Applicant further argues that “displaying the preparation amount” provides a practical application of reducing the burden of the user’s calculation, and that providing the amount reagent to add has the positive effect of quick and efficient electrophoresis as the user does not need to use time to calculate the amount of reagent necessary.
Examiner’s Response #1:
Applicant’s arguments have been fully considered and are persuasive. Examiner has withdrawn the 101 rejection.
Applicant’s Argument #2:
Applicant argues on pages 9-11 regarding the 35 U.S.C 103 rejection that the amended claim 1 limitations of “the processor is configured to read a specific value stored in a memory, and calculate the preparation amount of the reagent to a value that is an integer multiple of the specific value and is the minimum value greater than the required amount of the reagent” by incorporating depending Claim 10. Applicant respectfully submits that Multi-NA merely instructs a user to dispense an amount of reagent, and does not teach or suggest the specific claimed technical methods and systems of automatically calculating a preparation reagent amount by rounding up to an integer multiple of a specific value.
Examiner’s Response #2:
Applicant’s arguments have been fully considered, but are moot in view of the new grounds of rejections for claim 1 above. As Multi-NA teaches that the amount of the required reagent is calculated from the sample spreadsheet (see step 8 of Reagent Information 4.1.6 on page 77), which utilizes volume of reagent required for each run in the sample sheet and how many samples are run (see MultiNA window on page 73). In addition, as Multi-NA also teaches the required reagent is a round number, and that the volume of reagent required is in excess, it would be obvious to one of ordinary skill in the art to utilize the claimed technical methods and system of automatically calculating a preparation reagent to configured a processor to calculate the preparation amount of reagent as outlined in Claims 1 and 18. See the 103 rejections of Claim 1 and Claim 18 for more detail.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/R.L.G./Examiner, Art Unit 1795
/SHIZHI QIAN/Primary Examiner, Art Unit 1795
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