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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 25, 2026 has been entered.
The amendments have been thoroughly reviewed and entered. Any previous objection/ rejection not repeated herein has been withdrawn.
Applicant's arguments have been thoroughly reviewed but are deemed moot in view of the amendments, withdrawn rejections and new grounds for rejection. New and/or modified grounds for rejection, necessitated by the amendments, are discussed.
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 1-2 and 4-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 now recites "each of the one or more nozzles includes a slide ejector, the slide ejector configured to eject the corresponding at least one pipette tip column by sliding from a first position to a second position”. However, the “slide ejector” does not include any structural feature(s) related to how it actually works to eject the pipette tip and interacts with the claimed elements. This creates ambiguity in the sense that one does not know, for example, where the ejector means slides, its interaction with the annular protrusion and if it is actually part of the nozzle. The new recitation that the one or more nozzles “includes” a slide ejector does not necessarily mean that the slide ejector is in fact part of or formed on the nozzle and it could have a temporary character connotation. Thus, the scope of the claims is vague and indefinite.
Claims 6 and 7 indicate that the pipette tip is configured to be mounted to and released from the nozzle using a force in the range of about 50N to 160N. It is not clear how this now relates to the recitation that the slide ejector is configured to eject (release) a pipette tip from the column by sliding from a first position to a second position. Since the slide ejector does not include any structural elements capable of providing a force in the range of about 50N to 160N, this is confusing and indefinite.
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 1-2 and 4-20, as best understood, are rejected under 35 U.S.C. 103 as obvious over Tajima et al. (US 2010/0236324; hereinafter “Tajima”) in view of Stankus et al., (US 2016/0033543; hereinafter “Stankus”- cited in the PTO 892; filed May 16, 2025).
As to claim 1, Tajima teaches an automated separation system comprising:
a liquid handling device;
at least one pipette tip column 12 including a separation media 68, and
at least one or more one or more nozzles 14, each of the one or more nozzles including an annular protrusion configured to receive a corresponding one of the at least one pipette tip column (these annular protrusions are shown in the examiner modified Fig. 5 below), and
the system is configured to provide either positive or negative pressure to the at least one pipette tip column, thereby enabling aspiration and dispensing into and out the at least one pipette tip column.
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Note: The instant claims contain a large amount of functional/process language (ex: “the system is configured to provide either positive or negative pressure to the at least one pipette tip column, thereby enabling aspiration and dispensing into and out the at least one pipette tip column”). Functional/process 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. Therefore, if the prior art structure is capable of performing the function or intended use, then the prior art meets the limitation in the claims. The manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim (see MPEP § 2114 & § 2173.05(g)).
In this case, Tajima discloses the same function/process as recited in the claims. Tajima discloses each individual nozzle 14 is communication with a respective cylinder (pipette tip column 12). Tajima discloses each nozzle 14 is in communication with a plunger 43 fixed on a driving plate 45 which is driven up and down by the motor 49 enabling suction and discharge into and out of the at least one pipette column 12 (see para [0113] et seq.)
Tajima teaches each of the one more nozzles has been provided with a slide ejector (detachment part; see para [0043] et seq.) However, Tajima does not specifically recite the nozzle includes a slide ejector, the slide ejector configured to eject the corresponding at least one pipette tip column by sliding from a first position to a second position.
In the related art of automated separation systems, Stankus teaches a liquid handling device; at least one pipette tip column 50 and at least one or more one or more nozzles 40, each of the one or more nozzles including an annular protrusion 47, 48 configured to receive a corresponding one of the at least one pipette tip column, and the system is configured to provide either positive or negative pressure via air piston apparatus 20 to the at least one pipette tip column, thereby enabling aspiration and dispensing into and out the at least one pipette tip column. In so much as the nozzle includes a slide ejector as claimed, Stankus teaches at para [0168] a striker plate 28 (corresponds to claimed slide ejector) movable by a servo motor 29 up and down relative to the sockets on the air-piston apparatus. The striker plate comprises four, open-ended slots that align with the sockets in the air-piston apparatus into which the adaptors (corresponds to nozzles 40) can fit. The slots are dimensioned to fit around the adaptors (nozzles) between the upper lugs 46 and the positioning lugs 62. However, the upper end of any pipette or column engaged with the adaptor cannot pass through the slots of the striker plate (slide ejector) 28, so that downward movement of the striker plate relative to the adaptor (nozzle) can be used to push the pipette 50 or column 60 off the adaptor (nozzle) 40.
Accordingly it would have been obvious to one of ordinary skill in the art at the time the claimed invention was effectively filed to have included the system of Tajima, the slide ejector like that taught by Stankus, for the expected benefit providing a compact means to eject used pipette tips after use to avoid human interaction and possible contamination.
The applicant is advised that the Supreme Court recently clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, "[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp." An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR Int'l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143). In this case, it would have been obvious to substitute the detaching part of Tajima with the striker plate of Stankus since these both perform the removal of a pipette tip from a pipetted tip column by sliding from a first position to a second position.
As to claim 2, Tajima teaches each of the one or more nozzles 14 is provided with at least two annular protrusions both of which are arranged in a sealing engagement with the corresponding pipette tip column (these annular protrusions are shown in the examiner modified Fig. 5 above).
As to claim 4, Tajima teaches the at least one pipette tip column is configured to hold a liquid volume of at least about 20 mL. Note: “configured to hold” is considered a capability and not a limitation in the patentable sense. Nevertheless, Tajima teaches the capacity of the tip-shaped vessel is preferably one capable of handling a fluid in a quantity for example from several mL to several hundred mL (see para [0015] et seq.)
As to claim 5, Tajima teaches the at least one pipette tip column 12 is evenly tapered and configured to provide a tight seal between the inner surface of the pipette tip column and a corresponding one of the one or more nozzles (see para [0129] et seq., and Fig. 4). The recitation of such that the tight seal maintains a pressure of 3 PSI for 5 minutes or greater” is considered an intended use and does not recite any additional structure to the seal to accomplish the intended use. The intended use does not lead to a structural difference between the claimed invention and the prior art and has not received patentable weight.
As to claim 6, the recitation of “wherein seal between each of the one or more nozzles and the corresponding one of the at least one pipette tip column is configured to maintain a pressure or vacuum sealing for 5 minutes or greater with less than 5% pressure or vacuum loss” is considered an intended use and does not recite any additional structure to the seal to accomplish the intended use. The intended use does not lead to a structural difference between the claimed invention and the prior art and has not received patentable weight.
As to claims 7 and 8, the recitations “wherein the at least one pipette tip column is configured to be mounted to a corresponding one of the one or more nozzles using a force in the range of from about 50N to about 160N” and “is configured to be released from a corresponding one of the one more nozzles, by ejection using a force in the range of from about 50N to about 160N” are considered an intended use and force has not received patentable weight. Like the previously recited phrases “mountable” and “releasable”, the new recitation of “configured to” does not receive additional patentable weight and still only requires the ability to so perform. It does not constitute a limitation in any patentable sense.
As to claim 9, Tajima teaches an electric motor 49 provides the pressure to the at least one pipette tip column (see para [0113] et seq.)
As to claim 10, Tajima teaches at least two pipette tip columns separated from each other (see Fig. 1).
As to claim 11, Tajima teaches pipette tip column comprises packed separation media (see para [010] et seq.)
As to claim 12, Tajima teaches the separation media is selected from the group consisting of chromatography media (see para [0028] et seq.)
As to claim 13, Tajima teaches a method of separating a biomolecule from a liquid sample using the system according to claim 1, including aspirating the sample into each of the at least one pipette tip columns; such that biomolecules of the aspirated sample are allowed to react with the separation media for a period of time; and the sample comprising any unreacted biomolecules is dispensed from the pipette tip column (see para [0147] et seq.)
As to claim 14, Tajima teaches aspirating an eluent into each of the least one pipette tip columns; allowing the eluent to release biomolecules from the separation media; and dispensing the eluent including released biomolecules from the at least one pipette tip columns (see para [0054] et seq.)
As to claim 15, Tajima teaches the separated biomolecules are selected from the group consisting of proteins; peptides; and nucleic acids (see para [0188] et seq.)
As to claim 16, Tajima does not explicitly disclose a positive pressure of 3-5psi is applied to the column without substantially impairing a sealing of each of the at least one nozzles to a respective pipette tip column. However, Tajima does recognize that the pressure is operation parameter which is known in the art to be varied determined by an optimum parameter generating program that incorporates one or more column tips fitted to the nozzle and a designating data which designates the processing conducted using the column tips, generates, based on the designating data, a structural requirement data relating to corresponding column tip structure and a processing requirement data relating to the processing contents involving one or more types of subject fluids subjected to the suction or discharge of the column tips included in corresponding processing, and determines, based on the requirements generated, optimum parameter data prescribing quantities, pressure, flow rate, the number of cycles, time or position of the suction or discharge by the nozzle for the suction and discharge mechanism and the moving means (see Tajima para [0059] et seq.)
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of the claimed invention to determine the optimum range pressures used in Tajima based on the flow rate, the number of cycles, time or position of the suction or discharge by the nozzle for the suction and discharge mechanism and the moving means (see para [0059] et seq. of Tajima) .
As to claim 17, Tajima does teach the capacity of the tip-shaped vessel is preferably one capable of handling a fluid in a quantity for example from several mL to several hundred mL (see Tajima para [0015] et seq.), which is packed a chromatography media (see para [0056] et seq.). However, Tajima does not explicitly recite this as a kit with written instructions for performing such separation in a separate compartment. However, it would have been obvious to include in the system of Tajima written instructions for performing such separation in a separate compartment for the expected benefit of allowing the end user a means to use/operate the system.
As to claim 18, Tajima teaches in separate compartments, one or more of an equilibration buffer; a wash liquid; and an eluent inside a cartridge 58 (see Tajima para [0125] et seq.)
As to claim 19, Stankus discloses the annular protrusions 47, 48 are integral with the outer surface of the one or more nozzles (attached, see Fig. 6).
As to claim 20, Stankus discloses the annular protrusion 47, 48 is formed from an O-ring encircling the outer surface of each of the one or more nozzles (see para [0016] et seq.)
The Office has interpreted claim 20 as a product-by-process claim, since a product-by-process claims is one in which the structural scope of the product is defined at least in part in terms of the method or process by which it is made.
In this case, the end product is defined by the following steps: the annular protrusion is formed from rings encircling the outer surface of each of the one or more nozzles.
Applicant is reminded that the product-by-process claim is always to a product. The reference need only to substantially meet the structure of the end product. As set forth above, the annular protrusion formed as an O-ring of meets the structural requirements of the end product as set forth in the instant claims (see para [0028] et seq.).
Please note that an argument that the applied reference fails to meet all claimed process/limitations of making the end product does not overcome a proper 102/103 rejection because the reference need only to substantially meet all the structure of the end product, see MPEP 2113[R-1] and In re Fessmann, 489 F.2d 742, 744 180 USPQ 324, 326 (CCPA 1974).
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Response to Arguments
Applicant's arguments filed February 03, 2026 have been fully considered but they are not persuasive.
The examiner notes that the applicant’s arguments with respect to the previous prior art rejections do not apply to the instant rejections under 35 USC 103 (a). As recited above under 35 USC 112(b), it is not clear what applicant means by “each of the one or more nozzles includes as slide ejector”. Looking to applicant’s corresponding US 2023/0128571, para [0047], “[e]ach nozzle may be provided with a slide ejector that enables removal of the tip from the nozzle, as appropriate. As the skilled person will appreciate, the pipette tip column should fit sufficiently to the nozzle to stay in place during operation, while being easily removable after use, such as by the use of a slide ejector as exemplified if the drawings.” The language of “provided with” as used in the specification and claims is broad and does not necessarily mean the slide ejector is somehow attached to or part of the nozzle itself. In fact, applicant’s specification as shown in applicant’s Figs 2-6, indicates that the sliding ejector must be separate from the nozzle itself in order to move up and down along it. Even if it made sense that the slide ejector was considered part of the nozzle, applicant’s specification ‘571 at para [0090] states “FIG. 6 shows how a slide ejector may remove a pipette tip column top with strong force from pump nozzle”. However, specification does not provide how the nozzle itself is capable of causing the slide ejector to move from a first position to a second position to provide the “strong” force necessary to eject the pipette tip from the column to one of ordinary skill in the art. It is obvious that slide ejector requires some force-providing mechanism other than gravity to eject the tip from the nozzle, otherwise how does the pipette tip ever attach to the column since the sliding ejector would necessarily be at the lowest position as shown in Fig. 6. Furthermore, it is not clear how the pipette tip is configured to be mounted or released that would necessarily require a force from the slide ejector in the range of 50N to 160N (see claim 7 and 8). Thus, in so much as the claimed nozzle includes a slide ejector, then Stankus teaches a nozzle that “includes” a slide ejector.
With respect to claims 7 and 8, applicant argues that the phrase "configured to" functionally describe the structural element in the claims should provide patentable weight to the functionality of the structural elements in the claims. The examiner respectfully does not agree. In fact there is no difference in patentable weight afforded to the functional phrases following "configured to/for, adapted to/of, or capable of (mountable)" with respect the structure recited in the system claim. These phrases do not limit the scope of the mechanism and/or the function. That is, unless there is a lexicographic definition in the specification, these phrases are generally considered interchangeable. The determination of whether the functional/process limitation themselves limit the associated mechanisms depends on the specific facts of the case. In this case, as pointed out above, the functional language in the claims have not received patentable weight because they do not clearly define a specific structural feature or mechanism that performs the function as evidenced by applicant’s ‘571 at least at para [0090], rather the examined claims simply describe the intended use or result of the invention. See MPEP 2114. Thus, it is clear that a slide ejector moves a pipette tip column top with strong force from pump nozzle, but the slide ejector is not clearly defined with respect to any specific structural feature or mechanism in the specification that performs the function.
Thus, for the reasons delineated above, the claims remain rejected over the prior art.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure include
Wingo et al., (US 2013/0203089), teach an adapter containing a filter that can be used with pipetting devices, particularly robotic pipetting devices, to efficiently connect the pipetting device to pipette tips with minimal distortion of the pipette tip. The present invention also relates to a process and a system of using an adapter containing a filter that can be used with pipetting devices, particularly robotic pipetting devices, to assemble the adapter together with an unfiltered pipette tip on the site of application. The adapter and pipette tip are each stackable for saving space at the work station; and
Any inquiry concerning this communication or earlier communications from the examiner should be directed to P. Kathryn Wright whose telephone number is (571)272-2374. The examiner can normally be reached on 9:30am-7:30 pm EST.
Examiner interviews are available via telephone and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached on (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/P. Kathryn Wright/Primary Examiner, Art Unit 1798
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