DETAILED CORRESPONDENCE
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/26/26 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/26/26 has been considered by the examiner in as much as is disclosed in compliance with 37 CFR 1.97 and 37 CFR 1.98. However, the examiner notes that the EP Office Action cited therein has not been considered because it fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. In this case, the entire document is not in English, and there is no corresponding indication (X, Y, A, etc…) of the references cited therein. Therefore, there is not a sufficient explanation of relevance It has been placed in the application file, but the information referred to therein has not been considered.
Response to Amendment
As to the claim amendments and remarks filed on 1/26/26, the previous prior art rejections have been modified to address the amended claims.
As to the claim amendments and remarks, the previous 101 rejection has been modified.
Claim Status
Claims 16, 19-33 are pending with claims 16, 19-30 being examined and claims 31-33 deemed withdrawn.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 16, 19-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 16 is rejected under 101 for the following reasons
Step 2A, Prong One: Identify the law of nature/natural phenomenon/abstract ideas.
Claim 16 recites the abstract ideas of “ascertaining” a value of a characteristic variable of the acquired gas pressure, “comparing” the ascertained value with a calibration value, and “assigning” the pipette tip to a class which are all mental processes and/or math.
Step 2A Prong Two: Has the abstract idea been integrated into a particular practical application?
No.
After the assigning takes place, there are two limitations recited in the alternative – either preventing an imminent dosing task or continuing to carry out an imminent dosing task. Under BRI, the interpretation includes “carrying out execution” of the imminent dosing task “based on” the assigned class being correct. In this instance, there is no application as the pipette is just continuing to perform the pipetting duties. Therefore, in the situation where if the pipette tip is recognized as correct then the process continues or no action is taken. At best, this is recited at such a high level of generality that it amounts to just generally applying the abstract idea per MPEP 2106.05(f), and also is just generally linking the abstract idea to a field of use per MPEP 2106.05(h), which are not particular practical applications.
The claim also recites coupling a pipette tip to a gas displacement device, operating the gas displacement device to change the pressure, and acquiring the pressure. This is just using the gas displacement device with the pipette tip to gather data to be used in the abstract idea. However, data gathering to be used in the abstract idea does not integrate the judicial exception into a practical application because data gathering is insignificant extra-solution activity, and not a particular practical application. See MPEP 2106.05(g). Additionally, this is recited at such a high level of generality that it amounts to just generally applying the abstract idea per MPEP 2106.05(f), and also is just generally linking the abstract idea to a field of use per MPEP 2106.05(h), which are not particular practical applications.
Step 2B: Does the claim recite any elements which are significantly more than the abstract idea?
The claim recites the additional elements of coupling a pipette tip to a gas displacement device which includes a piston in a cylinder and the piston having a permanent magnet, operating the gas displacement device to change the pressure, and acquiring the pressure during aspirating and dispensing. These additional elements do not amount to significantly more as they are well-understood, routine, and conventional (WURC) in the art as evidenced by prior art Romer et al (WO 2020011787 where US 20210154659 is used as the corresponding document; hereinafter “Romer”; already of record) and Romer et al (US 20190358626; hereinafter “Romer II”; already of record). Romer and Romer II teaches coupling a pipette tip to a gas displacement device which includes a piston in a cylinder and the piston having a permanent magnet, operating the gas displacement device to change the pressure, and acquiring the pressure (Romer; [19, 48, 52, 112, 123], Figs. 1-5 & Romer II; [7, 49, 62, 63, 118, 121], Figs. 1-5). Also, see the references used in the 103 rejection below.
The dependent claims undergo a similar analysis and do not appear to resolve any of the above issues, and are therefore also rejected under 101.
Under step 2A prong 1, claim 19 and 20 recite details of the acquisition process which is part of the abstract idea. Also, claims 29, and 30 recite details of the characteristic variable which is part of the abstract idea.
Under step 2A prong 2, claims 19-22 and 24-28 all recite details of the data acquisition process, which is mere data gathering.
Under step 2B, claims 20, 23 all recite additional details of a piston within a pipettor that measures pressure, which is WURC (see references above and/or in the prior art rejection below). See also Reichmuth et al (US 20170341072; hereinafter “Reichmuth”; already of record, [3, 5, 19, 31, 55, 88-90], Fig. 1c) and Zuppiger et al (US 20070025882; hereinafter “Zuppiger”; already of record; Fig. 6, [46, 67]).
Claim Rejections - 35 USC § 103
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 16, 19, 21, 22, 24-30 are rejected under 35 U.S.C. 103 as being unpatentable over Pionke et al (US 20160045911; hereinafter “Pionke”; already of record) in view of Romer et al (US 20190358626; hereinafter “Romer II”; already of record) in view of Ott et al (US 20190143317; hereinafter “Ott”; already of record); or alternatively over Pionke et al (US 20160045911; hereinafter “Pionke”; already of record) in view of Romer et al (US 20190358626; hereinafter “Romer II”; already of record) in view of Hickey et al (US 20170224888; hereinafter “Hickey”; already of record).
As to claim 16, Pionke teaches a method for assigning a pipette tip to a particular class of pipette tips out of a plurality of different pipette tip classes (Pionke; Fig. 6, 7), the method comprising the following steps:
Coupling the pipette tip to a gas displacement device of a pipetting device in such a way that a device-side volume formed in the gas displacement device and a tip-side volume formed by the pipette tip communicate with one another, thereby forming a measurement volume comprising the communicating volumes: device-side volume and tip-side volume, Operating the gas displacement device and thereby changing a gas pressure in the measurement volume, wherein operating includes dispensing/aspirating in a first direction and aspirating/dispensing in a second direction (Pionke teaches coupling a pipette tip 88 to a gas displacement device 80, thereby creating a measurement volume of the gas displacement device and pipette tip; Fig. 4 [6, 116]. Poinke teaches aspirating and dispensing, which are in opposite directions; [33, 96, 107, 118, 120].),
Acquiring the gas pressure in the measurement volume over an entire acquisition period, where the entire acquisition period is defined as at least an amount of time for dispensing/aspirating in the first direction and dispensing/aspirating in the direction opposite to the first direction, Ascertaining at least one quantitative value of at least one characteristic variable characterizing the acquired gas pressure (Pionke teaches sensing pressure change profiles to acquire gas pressure in the volume of space of gas displacement device 80 and pipette tip 88; [118]. Pionke teaches determining a characteristic value as the pressure data or the pressure range data 230/240; Fig. 6-7, [110, 116-118, 129-140]. Poinke teaches aspirating and dispensing, which are in opposite directions; [33, 96, 107, 118, 120]. Poinke teaches pressure detection in order to determine if the pipette tip is suitable for use both aspirating and dispensing [107, 118]. Poinke teaches acquiring pressure values during dispensing [30-34, 108, 120] and also aspirating [118, 124, 129].),
Comparing the at least one ascertained quantitative value with at least one predetermined calibration value, and Assigning the pipette tip to a pipette tip class and outputting a class assigning information which represents the assigned pipette tip class based on the comparison result, and wherein the execution of an imminent dosing task is prevented, if the pipette tip, based on the assigned pipette tip class, is recognized as being an incorrect pipette tip for said imminent dosing task (Pionke teaches making comparisons to determine whether the pipette tip is suitable or not and outputting the information; Fig. 6, 7. [85, 107, 116-118, 129-140]. Pionke teaches continuing the dosing if the tip is suitable and removing the tip to prevent use if the tip is not suitable; Fig. 6-7).
Poinke does not specifically teach displacing a piston in a cylinder along a cylinder axis where the piston is displaced in the first direction for dispensing/aspirating and then moved opposite the first direction for aspirating/dispensing, where the piston exhibits at least one permanent magnet. However, Romer II teaches the analogous art of a pipette with a pressure sensor (Romer II; [49, 154], Figs. 1-3.), where the pipette aspirates and dispenses and displacing a piston in a cylinder along a cylinder axis (Romer; Figs. 1-3, [141-143]), where the piston exhibits at least one permanent magnet (Romer II teaches a permanent magnet 18 on piston 14 within cylinder 12 to aspirate and dispense; [62, 63, 118, 121], Figs. 1-3. Romer II teaches determining pressure during aspiration and dispensing; [94, 150]). It would have been obvious to one of ordinary skill in the art to have modified the gas displacement device of modified Pionke to have relied on a reciprocating piston with a magnet as in Romer II because Romer II teaches that using a reciprocating piston is a well-known configuration for operating a pipetting device (Romer II; [62, 63, 118, 121], Fig. 1-3) and because Romer II teaches that using pistons driven by magnets helps improve dynamic motion and also enables advantageous accelerations that are not possible using conventional pipette drives (Romer II; [62, 63]).
Although Pionke teaches classifying whether the pipette tip is suitable or not suitable based on comparing known pressure profiles for known pipette tips, Pionke does not specifically teach where the pipette tip classes differ with regard to a nominal pipetting volume or nominal pipetting volume range of the pipette tips assigned to the respective pipette tip classes and/or with regard to a shape of the pipette tips assigned to the respective pipette tip classes or a shape range of the pipette tips assigned to the respective pipette tip classes. However, Ott teaches the analogous art of a pipetting (Ott; Title) where pipette tips are classified and classes differ with regard to a nominal pipetting volume or nominal pipetting volume range of the pipette tips assigned to the respective pipette tip classes and/or with regard to a shape of the pipette tips assigned to the respective pipette tip classes or a shape range of the pipette tips assigned to the respective pipette tip classes (Ott teaches the determination of whether the correct pipette tip is connected [6, 106, 107] where determining the correct pipette tip can include the geometry/shape or volume/size of the pipette tip; [38]). It would have been obvious to one of ordinary skill in the art to have modified the classification of pipette tips as suitable or not suitable based on pressure profiles of Pionke to have included in the classification a determination of whether the correct size/volume or shape pipette tip was used as in Ott because Ott teaches that when pipetting that it is important to know when the correct pipette tip is attached (Ott; [6]).
Alternatively, although Pionke teaches classifying whether the pipette tip is suitable or not suitable based on comparing known pressure profiles for known pipette tips, Pionke does not specifically teach where the pipette tip classes differ with regard to a nominal pipetting volume or nominal pipetting volume range of the pipette tips assigned to the respective pipette tip classes and/or with regard to a shape of the pipette tips assigned to the respective pipette tip classes or a shape range of the pipette tips assigned to the respective pipette tip classes. However, Hickey teaches the analogous art of comparing pressures of pipette tips, where pipette tips are classified and classes differ with regard to a nominal pipetting volume or nominal pipetting volume range of the pipette tips assigned to the respective pipette tip classes and/or with regard to a shape of the pipette tips assigned to the respective pipette tip classes or a shape range of the pipette tips assigned to the respective pipette tip classes (Hickey teaches attaching an interchangeable tip to a gas generating device, and determining pressures and making a comparison of pressures where the difference in pressure enables the determination and classification of the size or characteristic of the interchangeable tip; [12, 24, 37, 44, 45], abstract, and Fig. 4-6). It would have been obvious to one of ordinary skill in the art to have modified the classification of pipette tips as suitable or not suitable based on pressure profiles of Pionke to have determined pipette size based on the difference in pressure profile as in Hickey because Hickey teaches that pipette tip size/characteristic classification can be determined based on pressure comparisons (Hickey; abstract, [12, 24]).
As to claim 19, modified Pionke teaches the method according to claim 16, wherein the ascertaining of at least one quantitative value is based on gas pressure values which are or were acquired during the operation of the gas displacement device, where the operation effects the acquired gas pressure values (Pionke teaches the values acquired during operation of the device; Fig. 6-7, [110, 116-118, 129-140]).
As to claim 21, modified Pionke teaches the method according to claim 16, wherein the ascertaining of at least one quantitative value is based on gas pressure values which are or were acquired temporally after the operation of the gas displacement device which effects the acquired gas pressure values (Pionke teaches acquiring pressure values over time during operation of the device; Fig. 6-7, [110, 116-118, 124, 125, 129-140]).
As to claim 22, modified Pionke teaches the method according to claim 21, wherein the operation which effects the acquired gas pressure values comprises the production of a gas pressure surge in the measurement volume (Pionke teaches measuring pressure over time intervals, where when pressure was applied it would surge/increase; Fig. 6-7, [110, 116-118, 124, 125, 129-140]).
As to claims 24-28, modified Pionke teaches the method according to claim 21, wherein the acquisition duration in a time interval of the pressure profile from at least the beginning to the end (see claim 21 above).
Modified Pionke does not specifically teach acquiring the pressure signal for between 3x-6x the time interval from the beginning of a gas pressure change until the first return to the initial value at the beginning of the gas pressure change. However, it would have been obvious to one of ordinary skill in the art to have acquired the pressure profile for a time period longer than the duration of the pressure change in order to provide the well-known concept of providing all of the pressure data necessary to determine if the pressure/pipette is suitable or not. It would have been obvious to one of ordinary skill in the art have selected any time longer, such as a time period of at least three times longer than the pressure change, and a time period of not more than 6 times longer than the pressure change in order to ensure that the time was long enough to capture all of the pressure data but not too long to capture excessive data that is useless since data at a time too far away from the pressure change would not be useful in evaluating the pressure change.
As to claim 29, modified Pionke teaches the method according to claim 16, wherein the characteristic variable is a mean of the acquired gas pressure (Pionke teaches that the pressure characteristic can include an average; [24, 25]).
As to claim 30, modified Pionke teaches the method according to claim 16, wherein the characteristic variable comprises at least one variable which characterizes a temporally transient course of the acquired gas pressure (Pionke teaches acquiring pressure values/profiles over time during operation of the device; Fig. 6-7, [110, 116-118, 124, 125, 129-140, 145]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Pionke/Romer II/Ott in view of Reichmuth et al (US 20170341072; hereinafter “Reichmuth”; already of record) or alternatively over Pionke/ Romer II/Hickey in view of Reichmuth et al (US 20170341072; hereinafter “Reichmuth”; already of record).
As to claim 20, modified Pionke teaches the method according to claim 19, with displacing a piston in a cylinder along a cylinder axis (The modification of the pipette of Pionke to include the piston of Romer II has already been discussed above in claim 16, and Romer II discusses controlling piston speed; [97]).
Pionke does not specifically teach the operation of the gas displacement device comprises a displacement of the piston at a constant piston velocity for a constant displacement duration, that the acquisition of a gas pressure in the measurement volume takes place during the constant displacement duration, and that the ascertaining of at least one quantitative value is based on gas pressure values acquired during the constant displacement duration. However, Reichmuth teaches the analogous art of a pipetting device which operates by displacing a piston in a cylinder along an axis, the operation of the gas displacement device comprises a displacement of the piston at a constant piston velocity for a constant displacement duration (Reichmuth teaches a movable part/plunger 12 that operates reciprocating up and down to aspirate; [3, 5, 19, 31, 55, 88-90], Fig. 1c. Reichmuth teaches operating the plunger at a constant speed; [32, 47, 101, 106]). It would have been obvious to one of ordinary skill in the art to have modified the gas displacement device of modified Pionke to have relied on a reciprocating piston at a constant velocity as in Reichmuth because Reichmuth teaches that using a reciprocating piston is a well-known configuration for operating a pipetting device (Reichmuth; [3, 5, 19, 31, 55, 88-90], Fig. 1c) and because Reichmuth teaches that it is preferable to keep the velocity constant (Reichmuth; [32, 47]). The resulting modification of modified Pionke with Reichmuth would result in the acquisition of a gas pressure in the measurement volume takes place during the constant displacement duration, and that the ascertaining of at least one quantitative value is based on gas pressure values acquired during the constant displacement duration because Pionke teaches measuring the pressure over time to determine whether the pipette tip is suitable where the modification with Reichmuth would mean that measuring would take place which the plunger of Reichmuth was displaced.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Pionke/Romer II/Ott alone or alternatively in view of Reichmuth et al (US 20170341072; hereinafter “Reichmuth”; already of record); or alternatively over Pionke/Romer II/Hickey alone or alternatively in view of Reichmuth et al (US 20170341072; hereinafter “Reichmuth”; already of record).
As to claim 23, modified Pionke teaches the method according to claim 22, with displacing a piston in a cylinder along a cylinder axis in a first direction and subsequently in a direction opposite to the first direction, the production of a gas pressure surge in the measurement volume comprises a piston movement in two opposite directions in the cylinder (The modification of the pipette of Pionke to include the piston of Romer II has already been discussed above in claim 16. Romer II teaches the piston moving downwards and then upwards in an opposite direction; Figs. 1-3, [141-143]. Romer II also teaches a pressure surge; [7, 139-144], Figs. 3b/3c).
Romer II teaches that the dispensing can occur in approximately 8 ms (Romer II teaches downward movement takes 4 ms, and that in addition to the reversal that the movement takes approximately 8 ms; [164, 167], Fig. 4). Romer II also teaches the stroke distance P/G; Fig. 3. However, Romer II does not specifically teach a stroke magnitude per direction of at least 0.5 mm each. However, the stoke magnitude and length of time for displacement would all depend on the volume of fluid to be aspirated (Romer II; [104, 140, 143, 145, 170]). Therefore, it is evident that Romer II recognizes that the stroke magnitude and movement duration are result effective variables since Romer II does teach that the plunger movement, including distance and speed, can be adjusted (Romer II; [104, 140, 143, 145, 170]) where the distance moved depends on the volume (Romer II; [104, 140, 143, 145, 170]). It would have been obvious to a person having ordinary skill in the art to modify modified Pionke’s plunger to have a stroke magnitude per direction of at least 0.5 mm each depending on the volume of fluid that is aspirated as suggested by Romer II (Romer II; [104, 140, 143, 145, 170]).
If it is deemed that modified Pionke does not teach a stroke magnitude per direction of at least 0.5 mm each with a total movement duration of no more than 12 ms, Reichmuth does teach that the plunger movement, including distance and speed, can be adjusted (Reichmuth; [55]) where the distance moved depends on the volume (Reichmuth; [107, 110]) and where the speed can control how accurate pipetting is while also ensuring that the speed is not unnecessarily long (Reichmuth; [87]). With respect to the stroke magnitude and total movement duration of the plunger, it would have been obvious to a person having ordinary skill in the art to modify modified Pionke’s plunger to have a stroke magnitude per direction of at least 0.5 mm each depending on the volume of fluid that is aspirated (Reichmuth; [55, 107, 110]) and also to modify modified Pionke’s plunger to have a total movement duration of no more than 12 ms for the purpose of ensuring that the pipetting process was not too long or too quick (Reichmuth; [87]). Therefore, it is evident that Reichmuth recognizes that the stroke magnitude and movement duration are result effective variables since Reichmuth does teach that the plunger movement, including distance and speed, can be adjusted (Reichmuth; [55]) where the distance moved depends on the volume (Reichmuth; [107, 110]) and where the speed can control how accurate pipetting is while also ensuring that the speed is not unnecessarily long (Reichmuth; [87]).
Claims 16, 19, 21, 22, 24-30 are rejected under 35 U.S.C. 103 as being unpatentable over Pionke et al (US 20160045911; hereinafter “Pionke”; already of record) in view of Romer et al (WO 2020011787 where US 20210154659 is used as the corresponding document; hereinafter “Romer”; already of record) in view of Ott et al (US 20190143317; hereinafter “Ott”; already of record); or alternatively over Pionke et al (US 20160045911; hereinafter “Pionke”; already of record) in view of Romer et al (WO 2020011787 where US 20210154659 is used as the corresponding document; hereinafter “Romer”; already of record) in view of Hickey et al (US 20170224888; hereinafter “Hickey”; already of record). Romer currently qualifies as prior art under 102(a)(1) as it is outside of the one-year grace period. The examiner notes that Romer was published on 1/16/20 which is more than one year before the 2/17/21 effective filing date of the instant application. Providing a certified translation of the foreign priority document would overcome the Romer reference.
As to claim 16, Pionke teaches a method for assigning a pipette tip to a particular class of pipette tips out of a plurality of different pipette tip classes (Pionke; Fig. 6, 7), the method comprising the following steps:
Coupling the pipette tip to a gas displacement device of a pipetting device in such a way that a device-side volume formed in the gas displacement device and a tip-side volume formed by the pipette tip communicate with one another, thereby forming a measurement volume comprising the communicating volumes: device-side volume and tip-side volume, Operating the gas displacement device and thereby changing a gas pressure in the measurement volume, wherein operating includes dispensing/aspirating in a first direction and aspirating/dispensing in a second direction (Pionke teaches coupling a pipette tip 88 to a gas displacement device 80, thereby creating a measurement volume of the gas displacement device and pipette tip; Fig. 4 [6, 116]. Poinke teaches aspirating and dispensing, which are in opposite directions; [33, 96, 107, 118, 120].),
Acquiring the gas pressure in the measurement volume over an entire acquisition period, where the entire acquisition period is defined as at least an amount of time for dispensing/aspirating in the first direction and dispensing/aspirating in the direction opposite to the first direction, Ascertaining at least one quantitative value of at least one characteristic variable characterizing the acquired gas pressure (Pionke teaches sensing pressure change profiles to acquire gas pressure in the volume of space of gas displacement device 80 and pipette tip 88; [118]. Pionke teaches determining a characteristic value as the pressure data or the pressure range data 230/240; Fig. 6-7, [110, 116-118, 129-140]. Poinke teaches aspirating and dispensing, which are in opposite directions; [33, 96, 107, 118, 120]. Poinke teaches pressure detection in order to determine if the pipette tip is suitable for use both aspirating and dispensing [107, 118]. Poinke teaches acquiring pressure values during dispensing [30-34, 108, 120] and also aspirating [118, 124, 129].),
Comparing the at least one ascertained quantitative value with at least one predetermined calibration value, and Assigning the pipette tip to a pipette tip class and outputting a class assigning information which represents the assigned pipette tip class based on the comparison result, and wherein the execution of an imminent dosing task is prevented, if the pipette tip, based on the assigned pipette tip class, is recognized as being an incorrect pipette tip for said imminent dosing task (Pionke teaches making comparisons to determine whether the pipette tip is suitable or not and outputting the information; Fig. 6, 7. [85, 107, 116-118, 129-140]. Pionke teaches continuing the dosing if the tip is suitable and removing the tip to prevent use if the tip is not suitable; Fig. 6-7).
Poinke does not specifically teach displacing a piston in a cylinder along a cylinder axis where the piston is displaced in the first direction for dispensing/aspirating and then moved opposite the first direction for aspirating/dispensing, where the piston exhibits at least one permanent magnet. However, Romer teaches the analogous art of a pipette with a pressure sensor (Romer; [123], Figs. 1-4.), where the pipette aspirates and dispenses and displacing a piston in a cylinder along a cylinder axis (Romer; Figs. 1-4, [123, 136]), where the piston exhibits at least one permanent magnet (Romer teaches a permanent magnet 18 on piston 14 within cylinder 12 to aspirate and dispense; [48, 52, 112], Figs. 1-4. Romer teaches determining pressure during aspiration and dispensing; [123, 147]). It would have been obvious to one of ordinary skill in the art to have modified the gas displacement device of modified Pionke to have relied on a reciprocating piston with a magnet as in Romer because Romer teaches that using a reciprocating piston is a well-known configuration for operating a pipetting device (Romer; [48, 52, 112], Figs. 1-4.) and because Romer teaches that using pistons driven by magnets helps improve dynamic motion and also enables advantageous accelerations that are not possible using conventional pipette drives (Romer; [48, 136]).
Although Pionke teaches classifying whether the pipette tip is suitable or not suitable based on comparing known pressure profiles for known pipette tips, Pionke does not specifically teach where the pipette tip classes differ with regard to a nominal pipetting volume or nominal pipetting volume range of the pipette tips assigned to the respective pipette tip classes and/or with regard to a shape of the pipette tips assigned to the respective pipette tip classes or a shape range of the pipette tips assigned to the respective pipette tip classes. However, Ott teaches the analogous art of a pipetting (Ott; Title) where pipette tips are classified and classes differ with regard to a nominal pipetting volume or nominal pipetting volume range of the pipette tips assigned to the respective pipette tip classes and/or with regard to a shape of the pipette tips assigned to the respective pipette tip classes or a shape range of the pipette tips assigned to the respective pipette tip classes (Ott teaches the determination of whether the correct pipette tip is connected [6, 106, 107] where determining the correct pipette tip can include the geometry/shape or volume/size of the pipette tip; [38]). It would have been obvious to one of ordinary skill in the art to have modified the classification of pipette tips as suitable or not suitable based on pressure profiles of Pionke to have included in the classification a determination of whether the correct size/volume or shape pipette tip was used as in Ott because Ott teaches that when pipetting that it is important to know when the correct pipette tip is attached (Ott; [6]).
Alternatively, although Pionke teaches classifying whether the pipette tip is suitable or not suitable based on comparing known pressure profiles for known pipette tips, Pionke does not specifically teach where the pipette tip classes differ with regard to a nominal pipetting volume or nominal pipetting volume range of the pipette tips assigned to the respective pipette tip classes and/or with regard to a shape of the pipette tips assigned to the respective pipette tip classes or a shape range of the pipette tips assigned to the respective pipette tip classes. However, Hickey teaches the analogous art of comparing pressures of pipette tips, where pipette tips are classified and classes differ with regard to a nominal pipetting volume or nominal pipetting volume range of the pipette tips assigned to the respective pipette tip classes and/or with regard to a shape of the pipette tips assigned to the respective pipette tip classes or a shape range of the pipette tips assigned to the respective pipette tip classes (Hickey teaches attaching an interchangeable tip to a gas generating device, and determining pressures and making a comparison of pressures where the difference in pressure enables the determination and classification of the size or characteristic of the interchangeable tip; [12, 24, 37, 44, 45], abstract, and Fig. 4-6). It would have been obvious to one of ordinary skill in the art to have modified the classification of pipette tips as suitable or not suitable based on pressure profiles of Pionke to have determined pipette size based on the difference in pressure profile as in Hickey because Hickey teaches that pipette tip size/characteristic classification can be determined based on pressure comparisons (Hickey; abstract, [12, 24]).
As to claim 19, modified Pionke teaches the method according to claim 16, wherein the ascertaining of at least one quantitative value is based on gas pressure values which are or were acquired during the operation of the gas displacement device, where the operation effects the acquired gas pressure values (Pionke teaches the values acquired during operation of the device; Fig. 6-7, [110, 116-118, 129-140]).
As to claim 21, modified Pionke teaches the method according to claim 16, wherein the ascertaining of at least one quantitative value is based on gas pressure values which are or were acquired temporally after the operation of the gas displacement device which effects the acquired gas pressure values (Pionke teaches acquiring pressure values over time during operation of the device; Fig. 6-7, [110, 116-118, 124, 125, 129-140]).
As to claim 22, modified Pionke teaches the method according to claim 21, wherein the operation which effects the acquired gas pressure values comprises the production of a gas pressure surge in the measurement volume (Pionke teaches measuring pressure over time intervals, where when pressure was applied it would surge/increase; Fig. 6-7, [110, 116-118, 124, 125, 129-140]).
As to claims 24-28, modified Pionke teaches the method according to claim 21, wherein the acquisition duration in a time interval of the pressure profile from at least the beginning to the end (see claim 21 above).
Modified Pionke does not specifically teach acquiring the pressure signal for between 3x-6x the time interval from the beginning of a gas pressure change until the first return to the initial value at the beginning of the gas pressure change. However, it would have been obvious to one of ordinary skill in the art to have acquired the pressure profile for a time period longer than the duration of the pressure change in order to provide the well-known concept of providing all of the pressure data necessary to determine if the pressure/pipette is suitable or not. It would have been obvious to one of ordinary skill in the art have selected any time longer, such as a time period of at least three times longer than the pressure change, and a time period of not more than 6 times longer than the pressure change in order to ensure that the time was long enough to capture all of the pressure data but not too long to capture excessive data that is useless since data at a time too far away from the pressure change would not be useful in evaluating the pressure change.
As to claim 29, modified Pionke teaches the method according to claim 16, wherein the characteristic variable is a mean of the acquired gas pressure (Pionke teaches that the pressure characteristic can include an average; [24, 25]).
As to claim 30, modified Pionke teaches the method according to claim 16, wherein the characteristic variable comprises at least one variable which characterizes a temporally transient course of the acquired gas pressure (Pionke teaches acquiring pressure values/profiles over time during operation of the device; Fig. 6-7, [110, 116-118, 124, 125, 129-140, 145]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Pionke/Romer/Ott in view of Reichmuth et al (US 20170341072; hereinafter “Reichmuth”; already of record) or alternatively over Pionke/ Romer/Hickey in view of Reichmuth et al (US 20170341072; hereinafter “Reichmuth”; already of record).
As to claim 20, modified Pionke teaches the method according to claim 19, with displacing a piston in a cylinder along a cylinder axis (The modification of the pipette of Pionke to include the piston of Romer II has already been discussed above in claim 16, and Romer II discusses controlling piston speed; [97]).
Pionke does not specifically teach the operation of the gas displacement device comprises a displacement of the piston at a constant piston velocity for a constant displacement duration, that the acquisition of a gas pressure in the measurement volume takes place during the constant displacement duration, and that the ascertaining of at least one quantitative value is based on gas pressure values acquired during the constant displacement duration. However, Reichmuth teaches the analogous art of a pipetting device which operates by displacing a piston in a cylinder along an axis, the operation of the gas displacement device comprises a displacement of the piston at a constant piston velocity for a constant displacement duration (Reichmuth teaches a movable part/plunger 12 that operates reciprocating up and down to aspirate; [3, 5, 19, 31, 55, 88-90], Fig. 1c. Reichmuth teaches operating the plunger at a constant speed; [32, 47, 101, 106]). It would have been obvious to one of ordinary skill in the art to have modified the gas displacement device of modified Pionke to have relied on a reciprocating piston at a constant velocity as in Reichmuth because Reichmuth teaches that using a reciprocating piston is a well-known configuration for operating a pipetting device (Reichmuth; [3, 5, 19, 31, 55, 88-90], Fig. 1c) and because Reichmuth teaches that it is preferable to keep the velocity constant (Reichmuth; [32, 47]). The resulting modification of modified Pionke with Reichmuth would result in the acquisition of a gas pressure in the measurement volume takes place during the constant displacement duration, and that the ascertaining of at least one quantitative value is based on gas pressure values acquired during the constant displacement duration because Pionke teaches measuring the pressure over time to determine whether the pipette tip is suitable where the modification with Reichmuth would mean that measuring would take place which the plunger of Reichmuth was displaced.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Pionke/Romer/Ott in view of Romer et al (US 20190358626; hereinafter “Romer II”; already of record) alone or alternatively in view of in view of Reichmuth et al (US 20170341072; hereinafter “Reichmuth”; already of record); or alternatively over Pionke/Romer/Hickey in view of Romer et al (US 20190358626; hereinafter “Romer II”; already of record) alone or alternatively in view of Reichmuth et al (US 20170341072; hereinafter “Reichmuth”; already of record).
As to claim 23, modified Pionke teaches the method according to claim 22, with displacing a piston in a cylinder along a cylinder axis in a first direction and subsequently in a direction opposite to the first direction, the production of a gas pressure surge in the measurement volume comprises a piston movement in two opposite directions in the cylinder (The modification of the pipette of Pionke to include the piston of Romer II has already been discussed above in claim 16. Romer II teaches the piston moving downwards and then upwards in an opposite direction; Figs. 1-3, [141-143]. Romer II also teaches a pressure surge; [7, 139-144], Figs. 3b/3c).
Romer II teaches that the dispensing can occur in approximately 8 ms (Romer II teaches downward movement takes 4 ms, and that in addition to the reversal that the movement takes approximately 8 ms; [164, 167], Fig. 4). Romer II also teaches the stroke distance P/G; Fig. 3. However, Romer II does not specifically teach a stroke magnitude per direction of at least 0.5 mm each. However, the stoke magnitude and length of time for displacement would all depend on the volume of fluid to be aspirated (Romer II; [104, 140, 143, 145, 170]). Therefore, it is evident that Romer II recognizes that the stroke magnitude and movement duration are result effective variables since Romer II does teach that the plunger movement, including distance and speed, can be adjusted (Romer II; [104, 140, 143, 145, 170]) where the distance moved depends on the volume (Romer II; [104, 140, 143, 145, 170]). It would have been obvious to a person having ordinary skill in the art to modify modified Pionke’s plunger to have a stroke magnitude per direction of at least 0.5 mm each depending on the volume of fluid that is aspirated as suggested by Romer II (Romer II; [104, 140, 143, 145, 170]).
If it is deemed that modified Pionke does not teach a stroke magnitude per direction of at least 0.5 mm each with a total movement duration of no more than 12 ms, Reichmuth does teach that the plunger movement, including distance and speed, can be adjusted (Reichmuth; [55]) where the distance moved depends on the volume (Reichmuth; [107, 110]) and where the speed can control how accurate pipetting is while also ensuring that the speed is not unnecessarily long (Reichmuth; [87]). With respect to the stroke magnitude and total movement duration of the plunger, it would have been obvious to a person having ordinary skill in the art to modify modified Pionke’s plunger to have a stroke magnitude per direction of at least 0.5 mm each depending on the volume of fluid that is aspirated (Reichmuth; [55, 107, 110]) and also to modify modified Pionke’s plunger to have a total movement duration of no more than 12 ms for the purpose of ensuring that the pipetting process was not too long or too quick (Reichmuth; [87]). Therefore, it is evident that Reichmuth recognizes that the stroke magnitude and movement duration are result effective variables since Reichmuth does teach that the plunger movement, including distance and speed, can be adjusted (Reichmuth; [55]) where the distance moved depends on the volume (Reichmuth; [107, 110]) and where the speed can control how accurate pipetting is while also ensuring that the speed is not unnecessarily long (Reichmuth; [87]).
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to applicant's disclosure include;
Zuppiger et al (US 20070025882; hereinafter “Zuppiger”; already of record) teaches pressure curves in pipettes tips are known and that geometry/shape, volume, and type of pipette tip all affect the pressure profile along with other variables; [46]. Zuppiger teaches that the pressure characteristic can be evaluated both during aspiration and dispensing; [46].
Response to Arguments
Applicant’s arguments filed on 1/26/26 with respect to the previous prior art rejection have been considered but are moot because the arguments are towards the amended claims and not the current ground of rejection.
Applicant's arguments towards the 35 USC 101 rejection have been fully considered but they are not persuasive.
Applicants argue on page 11 of their remarks that there is not a judicial exception recited in the claims. The examiner respectfully disagrees and notes that under step 2A prong one that Claim 16 recites the abstract ideas/judicial exception of “ascertaining” a value of a characteristic variable of the acquired gas pressure, “comparing” the ascertained value with a calibration value, and “assigning” the pipette tip to a class which are all mental processes and/or math.
Applicants argue on pages 11-12 of their remarks that the claims are integrated into a particular practical application under Step 2A Prong Two. Applicants specifically argue that the claims provide an improvement to technology because the prevention of execution of a dosing task takes place. However, after the assigning takes place, there are two limitations recited in the alternative – either preventing an imminent dosing task or continuing to carry out an imminent dosing task. Under BRI, the interpretation includes “carrying out execution” of the imminent dosing task “based on” the assigned class being correct. In this instance, there is no application as the pipette is just continuing to perform the pipetting duties. Therefore, in the situation where if the pipette tip is recognized as correct then the process continues or no action is taken. At best, this is recited at such a high level of generality that it amounts to just generally applying the abstract idea per MPEP 2106.05(f), and also is just generally linking the abstract idea to a field of use per MPEP 2106.05(h), which are not particular practical applications. The examiner notes that applicants could consider breaking the limitation down into an “and” clause instead of an “or” clause such that it was clear that the limitations were not in the alternative.
Applicants argue on page 13 of their remarks that the claims are not WURC under Step 2B. However, the examiner respectfully disagrees and directs applicants attention to the references used in the 101 rejection above to show that the additional elements are WURC.
Conclusion
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/BENJAMIN R WHATLEY/Primary Examiner, Art Unit 1798
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