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 .
Election/Restrictions
Applicant’s election without traverse of group I (claims 1-9) in the reply filed on 10/31/25 is acknowledged. Claims 10-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group(s), there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 3/20/23, 7/6/23 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Status
Claims 1-21 are pending with claims 1-9 being examined and claims 10-21 deemed withdrawn.
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 2-3 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 pre-AIA the applicant regards as the invention.
As to claims 2-3, it is unclear how the number of cells in the second volume is determined with the impedance sensor. The impedance sensor is with respect to the first volume, and the camera is with respect to the second volume in claim 1, and therefore it is unclear how the impedance sensor can gather data with respect to the second volume.
Appropriate correction and/or clarification is required.
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 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over WaferGen (US 20150362420; hereinafter “WaferGen”; already of record) in view of Lei et al (US 20250012703; hereinafter “Lei”) in view of Takeda et al (US 20190339189; hereinafter “Takeda”).
As to claim 1, WaferGen teaches the end effector assembly (WaferGen; Fig. 3, 4, 10) comprising:
a tool body configured to be mounted to a robotic arm (WaferGen teaches the top portion of 200; Fig. 10. WaferGen also teaches top of 42; Fig. 4);
an impedance-measuring tip coupled to the tool body, the impedance-measuring tip defining a first volume configured to receive a fluid and a first dispensing outlet for dispensing the fluid from the first volume, the impedance-measuring tip comprising an impedance-measuring sensor configured to output a signal indicative of a change in impedance of the fluid advanced out of the first dispensing outlet, the change in impedance being indicative of cells or other objects passing from the first volume out of the first dispensing outlet (WaferGen teaches a tip 200 which includes an impedance sensor to count or identify cells; Fig. 10, [14, 56, 79]);
a tip extension fluidically coupled to the impedance-measuring tip, the tip extension defining a second volume for receiving the fluid from the first dispensing outlet (WaferGen teaches tip extension 210; [53], Fig. 10. WaferGen teaches tip extension 43; [44], Fig. 4);
a pump coupled to the impedance-measuring tip and operable to dispense the fluid from the first volume into the second volume and from the second volume into a receptacle via a second dispensing opening formed in the tip extension (WaferGen teaches a connection to a fluid source 235 such that the liquid and cells are dispensed into a receptacle; [79], Fig. 10. WaferGen teaches that the fluid is aspirated and/or dispensed in [56], whereby this fluid movement would require a pump in order to cause the fluid to flow).
Note: The instant Claims contain a large amount of functional language (ex: “configured to…”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
WaferGen does not specifically teach a camera coupled to the tool body and configured to capture image data, wherein the image data captures at least a visual representation of the cells or other objects. However, Lei teaches the analogous art of dispensing cells, a camera coupled to the tool body and configured to capture image data, wherein the image data captures at least a visual representation of the cells or other objects (Lei teaches an imaging device that is coupled to the cartridge holder/tool body that holds the dispensing cartridge; Fig. 6-7. Lei teaches after detecting impedance with sensors 116/730/728, then an image is taken in channel 110 to dispense fluids to various locations based on the detection results; [31, 50, 53, 55, 61, 64, 78, 19, 84], Fig. 3-5, 8. Lei teaches using the information to count or identify cells; [36, 38, 47, 60]). It would have been obvious to one of ordinary skill in the art to have modified the cell counting device of WaferGen to have included a camera to further verify cell count as in Lei because Lei teaches that imaging the cell helps further assist in the verification of accurate cell dispensing (Lei; [15, 16]) and also that imaging after measuring impedance helps to direct the dispensing location (Lei; Fig. 5-6), and because the characteristics of the change in impedance can further assist in cellular recognition via imaging (Lei; [31]).
Modified WaferGen does not specifically teach the camera captures data of cells or other objects in the second volume at the tip. However, Takeda teaches the analogous art of dispensing cells and counting them using a camera that captures data of cells or other objects in the second volume at the tip (Takeda teaches that the image is taken to count the cells at the tip with camera 76; [73, 75, 117], Fig. 9A, 10, 14A). It would have been obvious to one of ordinary skill in the art to have modified impedance detection in the pipette tip which further images and counts the cells of modified WaferGen to counts in the second volume at the tip as in Takeda because Takeda teaches that a camera taking an image of the tip of the dispenser is a well-known technique to count cells (Takeda; [73, 75, 117], Fig. 9A, 10, 14A). Further, without some statement of criticality or unexpected results, it would have been obvious to one of ordinary skill in the art at the time the invention was made to rearrange the camera that captures data of cells or other objects after impedance detection of modified WaferGen to capture data in the second volume at the tip as in Takeda to allow for downstream imaging at the tip since it has been generally recognized that to shift location of parts when the operation of the device is not otherwise changed is within the level of ordinary skill in the art, In re Japikse, 86 USPQ 70; In re Gazda, 104 USPQ 400.'
As to claim 2, modified WaferGen teaches the end effector assembly of claim 1, further comprising: a controller communicatively coupled to the impedance-measuring sensor, wherein the controller is configured to determine a number of cells or other objects present in the second volume based on the signal from the impedance-measuring sensor (In as much as claimed and as best understood, WaferGen teaches a tip 200 which includes an impedance sensor to count or identify cells using a processor; Fig. 10, [14, 24, 39, 56, 77, 79]).
As to claim 3, modified WaferGen teaches the end effector assembly of claim 1, further comprising: a controller communicatively coupled to the impedance-measuring sensor and the camera, wherein the controller is configured to: determine a number of cells or other objects present in the second volume based on the signal from the impedance-measuring sensor; and confirm the number of cells or other objects present in the second volume based on the image data (In as much as claimed and as best understood, WaferGen teaches a tip 200 which includes an impedance sensor to count or identify cells using a processor; Fig. 10, [14, 24, 39, 56, 77, 79]. The modification of the device with the second volume of WaferGen to include the camera to count cells of Lei has already been discussed above. Lei teaches using the information to count or identify cells; [36, 38, 47, 60]. Lei teaches that counting the cells via the camera further assists in the verification of accurate cell dispensing; [15, 16]).
As to claim 4, modified WaferGen teaches the end effector assembly of claim 1, wherein the camera is communicatively coupled to a display displaying the image data (WaferGen teaches a computer with a GUI to display and a database with the cell number for counting by a user, and the only way a user could do this would be via a display; [18, 24, 77]. The modification of the device of WaferGen to include the camera of Lei has already been discussed above. Further, Lei teaches a computer that stores image data where the examiner believes that any computer that stored image data would also display it since there would be no other way for a user to access an image aside from a display. Additionally, the modification of the device of WaferGen to include the camera of Takeda has already been discussed above, and Takeda teaches displaying the image results; Fig. 10).
As to claim 5, modified WaferGen teaches the end effector assembly of claim 1, wherein the pump is further configured to draw the fluid into the first volume through the second volume (How the pump operates is a matter of intended use, not further defining the apparatus structure. WaferGen teaches a connection to a fluid source 235 such that the liquid and cells are dispensed into a receptacle; [79], Fig. 10. WaferGen teaches that the fluid is aspirated and/or dispensed in [56], whereby this fluid movement would require a pump in order to cause the fluid to flow).
As to claim 6, modified WaferGen teaches the end effector assembly of claim 1, further comprising a tool light fixture coupled to the tool body and configured to backlight the second volume relative to the camera (The modification of the device of WaferGen to include the camera coupled to the tool body of Lei has already been discussed above. Lei teaches that the camera includes an illumination source; [73, 76], Fig. 6-7).
As to claim 7, modified WaferGen teaches the end effector assembly of claim 1, wherein the impedance-measuring tip has a fluid volume capacity of up to about 200 microliters (WaferGen teaches that the amount of fluid dispensed into wells can be 500 nL; [27, 65]. Therefore, the impedance measuring tip volume would be a volume that accommodates the dispensed volume of 500 nL). Further, with respect to the volume of the tip, it would have been obvious to a person having ordinary skill in the art to modify WaferGen’s volume to be 200 uL or less the purpose of ensuring that the fluid was small enough to not waste fluid and to control nanoliter dispense volumes and also to ensure that the impedance measurements were accurate as too large of a volume would prevent accurate readings and also based on the species or desired application since the volume can vary based on these factors (WaferGen; [62]), and also because these volumes are known to be used for thermal cycling (WaferGen; [65]). Therefore, it is evident that WaferGen recognizes that the volume is a result effective variable since the volume can vary based on the desired application or species (WaferGen; [62]) and since varying the volume affects how much fluid and sample pass by the sensor ensuring that measurements are accurate and also ensuring that nanoliter dispense volumes are maintained accurately.
As to claim 8, modified WaferGen teaches the end effector assembly of claim 1, wherein the tip extension has a fluid volume capacity of up to about 2.0 microliters (WaferGen teaches that the amount of fluid dispensed into wells can be 500 nL; [27, 65]. Therefore, the extension tip volume would be a volume that accommodates the dispensed volume of 500 nL). Further, with respect to the volume of the tip, it would have been obvious to a person having ordinary skill in the art to modify WaferGen’s volume to be 200 uL or less the purpose of ensuring that the fluid was small enough to not waste fluid and to control nanoliter dispense volumes and also to ensure that the impedance measurements were accurate as too large of a volume would prevent accurate readings and also based on the species or desired application since the volume can vary based on these factors (WaferGen; [62]), and also because these volumes are known to be used for thermal cycling (WaferGen; [65]). Therefore, it is evident that WaferGen recognizes that the volume is a result effective variable since the volume can vary based on the desired application or species (WaferGen; [62]) and since varying the volume affects how much fluid and sample pass by the sensor ensuring that measurements are accurate and also ensuring that nanoliter dispense volumes are maintained accurately.
As to claim 9, modified WaferGen teaches the end effector assembly of claim 1, wherein the pump is operable to dispense the fluid from the first volume into the second volume and from the second volume into a waste well via the second dispensing opening formed in the tip extension (How the pump operates is a matter of intended use, not further defining the apparatus structure. WaferGen teaches a connection to a fluid source 235 such that the liquid and cells are dispensed into a receptacle; [79], Fig. 10. WaferGen teaches that the fluid is aspirated and/or dispensed in [56], whereby this fluid movement would require a pump in order to cause the fluid to flow. The examiner notes that based on the detection that Lei dispenses into a waste; Fig. 3, 5).
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to applicant's disclosure include;
Lei et al (US 20250012703; hereinafter “Lei”) teaches the imaging caera aligns with waste or reservoir [58], and that the imager can move or the cartridge can move [74]. Lei teaches various dispensing volumes are known; [26]. Lei teaches a holder 506 for a robitc arm; [77].
Takeda et al (US 20190339189; hereinafter “Takeda”) teaches dispense volumes of .3 uL; [117].
Yu et al (US 20140030799; hereinafter “Yu”) teaches a sample in a channel with devices that detect impedance and optical; [150], Fig. 3.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Benjamin R Whatley whose telephone number is (571)272-9892. The examiner can normally be reached on Mon- Fri 8am-5pm.
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/Benjamin R Whatley/Primary Examiner, Art Unit 1798