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 .
This action is in response to applicant’s “Remarks” filed September 02, 2026. Applicant's arguments with respect to prior rejection of claims 1-11 under 35 USC 102(a)(1)/(a)(2) rejection over Lapham are persuasive and has been withdrawn. However, upon further consideration, new grounds of rejection have been applied below. The replacement grounds address the plate, movable support, drive structure and concurrent dispensing expressly. The erroneous Lapham reference numeral identifications and previous interpretation of functional language are not maintained.
Claim Interpretation
The below patentability analysis provides one or more interpretations and claim mappings of the claimed structures and/or limitations although other interpretations may be possible. In the patentability analysis, the Office applies the broadest reasonable interpretation (BRI) consistent with the specification. However, specific limitations from the specification are not read into the claims. See MPEP §§2111, 2173.01 I.
For example, the claim limitation “filter plate” is construed in the context of the multi-well plate described in para. [0028] of applicant’s US 2024/0103025 (hereinafter ‘025), which identifies a body with fluid-receiving wells and positioning features without identifying a filtering insert or filtration operation. Claim 1 requires the recited wells and coupling to the deck, but does not require a membrane, filtered outlet, outlet cap or filtration step. The claim limitations “deck module” and “liquid handler member” identify laboratory plate support and liquid-handling structures in their full claim context and have not been treated as nonce terms because “module” or “member” is used. The claim is not limited to a particular tray geometry or exactly six-tip embodiment (due to the comprising language). The “and/or” language in the claim 1 permits the dispensing alternative and does not require concurrent aspiration.
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f):
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
i. “an agitating member adapted to move the at least one filter plate according to an agitation system. Term “member” is a generic placeholder, “agitation” and “adapted to move” express its function without identifying the performing mechanism. Thus, this limitation has been interpreted under 112(f) as a vortex plate 116 as described in para [0027] of ‘025 or structural equivalences thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f), it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) by reciting sufficient structure to perform the claimed function; or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4, 5, 6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Toi et al., (US 20040096365; hereinafter “Toi”) in view of Hafner (US 20070177457).
Regarding claim 1, Toi discloses a drug processing system (Toi discloses automated liquid handling for drug-metabolism experiments. See paras. [0002]-[0004]) comprising:
“a workstation”; Toi discloses main body 2 containing robot 5, head 6 and labware and connected to controller 3. See paras. [0022]-[0025] and Fig. 1.
“at least one filter plate operably coupled with the at least one deck module, the at least one filter plate having a plurality of wells to receive a fluid therein;” Toi discloses microplate 11 with a plurality of fluid-receiving wells, positioned on shaker 13. Under the interpretation above, microplate 11 corresponds to the plate. Coupling to the substituted movable support is supplied by Hafner as discussed below. See paras. [0024] and [0027] and Fig. 1.
“an agitating member adapted to move the at least one filter plate according to an agitation system; and” Toi discloses shaker 13 moving microplate 11. Hafner supplies the identified drive structure for the§ 112(f) comparison, See para. [0027] and Fig. 1.
“a liquid handler member adapted to selectively add a fluid to at least one of the plurality of wells and/or remove a fluid from the at least one of the plurality of wells according to a liquid handling system;” Toi discloses robot 5, head 6 and tips 8 for suction and expulsion at selected wells. See paras. [0023]-[0024] and [0028]-[0029] and Figs. 1-3.
“wherein the agitating member is adapted to move the at least one filter plate while the liquid handler member selectively adds and/or removes the fluid from the at least one of the plurality of wells.” Toi discloses dispensing during incubation when plate excursion is small relative to well diameter, and incubation is defined as shaking the plate at a fixed temperature. Toi discloses the steps as concurrency rather than separate operations assumed to overlap. See paras. [0027] and [0044].
Toi does not disclose “at least one deck module movably positionable within the workstation” and does not identify the internal drive structure of shaker 13.
Hafner discloses support plate 2 with recess 2A and fixing element 8, carrying the microplate 7 with mixing apparatus 10 on powered displacement device 30 among P1-P3 within an apparatus housing. The support plate 2 corresponds to the deck module; recess 2A and fixing element 8 couple the microplate 7 to it. Hafner discloses a motor 3, unbalance element 5 and elastic bearings 6 moving support plate 2, see para [0034] et seq. and Figs. 1-6.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Hafner's compact support/mixing assembly and positioning device in Toi's workstation to provide repeatable plate positioning while retaining Toi's concurrent dispensing mode, because Hafner identifies compact integration and return to a defined position as advantages. One of ordinary skill in the art would have had a reasonable expectation of success because both references handle supported multiwell plates and matching the recess/well pitch preserves well access. Hafner permits amplitude/frequency adjustment, see para [0031] et seq., and Toi demonstrates restricted-excursion dispensing, see para [0044] et seq. The stage is stationary during dispensing while the local drive agitates the plate. Hafner's identified
plate moving mechanism supplies the structural equivalence finding set out above.
Regarding claim 4, Toi in view of Hafner teaches the system of claim 1, and further teaches “wherein the liquid handling member comprises a first robotic arm movable between a plurality of positions within the workstation.”. Toi discloses a robot 5 with head 6 at its end, moved in three orthogonal axes by stepper or servo motors. The robot 5 corresponds to the first robotic arm. See paras. [0022]-[0023] and Fig. 1. The claim 1 modification retains that robot and its selected-well access.
Regarding claim 5, Toi in view of Hafner teaches the system of claim 4. Toi does not expressly illustrate “wherein the liquid handling member further comprises a six tip member adapted to simultaneously add and/or remove the /1.uid from six wells of the filter plate.”. It discloses removable well-pitch tips, twelve syringe positions driven by one motor, and tip arrangements selected from destination-well information; examples use five or eleven attached tips. See paras. [0023]-[0024], [0029], [0035]-[0038] and [0044]-[0045], and claims 1-2. It would have been obvious to one of ordinary skill in the art before the effective filing date to configure six attachments for six destination wells, because matching the attachment count to the specified well batch implements Toi's disclosed configuration technique and avoids unused tips and reagent. One of ordinary skill in the art would have had a reasonable expectation of success because the common motor actuates the attached tips together and the well pitch is matched. Six is the proposed configuration, not an express six-tip example or an assertion that twelve tips anticipate six.
Regarding claim 6, Toi in view of Hafner teaches the system of claim 1. Hafner is relied upon for “further comprising a plate mover adapted to move the at least one filter plate and/or the at least one deck module to a plurality of positions within the workstation.”. Hafner discloses device 30, rails 31A/32A, slides 31B/32B and motors 31C/32C moving the supported plate assembly among P1-P3, see Fig. 6 and para [0044] et seq. It would have been obvious to one of ordinary skill in the art before the effective filing date to use that mover for repeatable station positioning, for the reasons given for claim 1. One of ordinary skill in the art would have had a reasonable expectation of success because Hafner already moves a supported multiwell plate and the stage can remain parked during concurrent dispensing/local agitation.
Regarding claim 10, Toi in view of Hafner teaches the system of claim 1. Toi's general-purpose personal computer controller implies “a memory adapted to store non-transitory computer executable instructions; and”. See paras. [0022] and (0026]. Toi does not expressly state the complete trigger rule “a processor adapted to interface with the memory, wherein upon receiving a command to initiate the liquid handling system, the processor is adapted to execute the non-transitory computer executable instructions to cause the processor to automatically activate the agitation system and selectively add the fluid to at least one of the plurality of wells and/or remove the fluid from the at least one of the plurality of wells.”. It discloses computer-controlled protocol execution and concurrent dispensing/shaking. See paras. [0022], [0028] and [0043]-[0044] and Fig. 6. Hafner discloses software-specified shaking periods and timed motor activation. See the description of Fig. 5. It would have been obvious to one of ordinary skill in the art before the effective filing date to program the liquid-handling start command to activate agitation for that concurrent protocol, because the schedule coordinates the disclosed reagent delivery and mixing controls and avoids a separate shaker-start operation. One of ordinary skill in the art would have had a reasonable expectation of success because those controls are already computer-actuated; the change schedules their commands without requiring a new sensing principle.
Claims 2, 3 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Toi in view of Hafner as applied to claim 1 above, and further in view of Zuppiger et al., (US 20090097948; hereinafter “Zuppiger”).
Regarding claim 2, Toi in view of Hafner teaches the system of claim 1. Toi does not expressly disclose “wherein the agitating member comprises a vortex plate adapted to move at a selectable speed.” Zuppiger discloses a microplate support surface 28, vortex-producing movement and selectable frequencies and deflections. See Zuppiger paras. [0027]-[0038], and Fig. 4. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Zuppiger’s selectable local drive with Hafner's interstation stage while retaining Toi's dispensing mode, because Zuppiger provides controlled plate mixing with reduced transmitted vibration near the liquid-handling equipment. One of ordinary skill in the art would have had a reasonable expectation of success because Zuppiger retains multiwell plates and adjusts deflection to well dimensions; restricted excursion preserves Toi's dispensing clearance. Higher settings may provide vortex mixing between dispensing operations.
Regarding claim 3, Toi in view of Hafner and Zuppiger teaches the system of claim 2. Toi does not expressly state “wherein the vortex plate is adapted to move between approximately 25 revolutions per minute and approximately 300 revolutions per minute.” Zuppiger discloses circle patterns and a selectable frequency between
0.1 to over 4000 Hz. See Zuppiger paras. [0038]-[0039] and Fig. 4. In circle mode,
one complete orbit is one cycle which is approximately 25-300 orbital rpm that equals approximately 0.417-5 Hz. This is an examiner calculation, not a relabeling of motor shaft speed. Regardless, it would have been obvious to one of ordinary skill in the art
before the effective filing date of the claimed invention to provide selection throughout that interval, because Zuppiger identifies frequency and deflection as adjustable mixing variables related to well dimensions. One of ordinary skill in the art would have had a reasonable expectation of success because its measured X/Y motion provides selectable circle patterns within the disclosed envelope. The claimed range selection requires to evidence of criticality or unexpected results. MPEP 2144.05.
Regarding claim 11, Toi in view of Hafner teaches the system of claim 1. Toi does not expressly specify the circular path in “wherein the agitating member is adapted to move the at least one filter plate in a circular motion while the liquid handler member selectively adds and/or removes the fluid from the at least one of the plurality of wells.”. Zuppiger discloses circle and complex circular plate-motion patterns. See Zuppiger para. [0039] and Fig. 4. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the desired mixing path while retaining Toi's express concurrent dispensing mode, because the pattern provides controlled multiwell mixing with adjustable deflection and reduced transmitted vibration. One of ordinary skill in the art would have had a reasonable expectation of success because measured X/Y motion permits restricted radius circular movement that preserves the well access principle of Toi (see para. [0044] et seq).
Claims 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Toi in view of Hafner as applied above, and further in view of Glezer et al., (US 20180074082; hereinafter “Glezer”). .
Regarding claim 7, Toi in view of Hafner teaches the system of claim 6. Toi does not disclose a separate plate-transfer arm providing “wherein the plate mover comprises a second robotic arm movable between a plurality of positions within the workstation.”.
Glezer discloses robotic arm 26 transferring plates among shelves 22, deck 40 and instruments including shaker 28, separately from liquid dispensing device.
See Glezer paras. [0073]-[0080], and Figs. 2-3. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add that separate arm to load and unload plates without manual intervention, because Glezer teaches this division of laboratory handling tasks. One of ordinary skill in the art would have had a reasonable expectation of success because Glezer already performs programmed multiwell plate transfers to a deck and shaker. Exterior gripping and matched seating preserve those interfaces and the transfer occurs between liquid handling operations.
Regarding claim 9, Toi in view of Hafner teaches the system of claim 1. Toi's protocol/layout information does not provide “further comprising a visual identification member disposed on at least one of the at least one deck module or the at least one filter plate.” Glezer discloses barcodes physically placed on plates and barcode reader 24. The plate barcode, not the remote reader, corresponds to the identification member. See Glezer paras. [0073] and [0077]. Glezer expressly places the barcode on each plate or reservoir and describes reader verification before arm transfer (see para [0077] et seq.) It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place that barcode on the plate to verify its identity and associate it with the correct protocol, because Glezer teaches that identification technique for the same labware. One of ordinary skill in the art would have had a reasonable expectation of success because an exterior barcode does not alter the wells or plate motion and can be read while on the positioning stage.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Toi in view of Hafner as applied to claim 6 above, and further in view of Gilligan et al., (WO 2020098957; hereinafter “Gilligan”; see corresponding US 20220011331 for citations below).
Regarding claim 8, Toi in view of Hafner teaches the system of claim 6. Toi does not disclose “further comprising an adapter bracket adapted to operably couple with at least a portion of the at least one filter plate, the adapter bracket including a
sidewall member and at least one groove formed on at least a portion of the sidewall member, wherein the at least one groove is adapted to be engaged by the plate mover during movement thereof within the workstation.”
Gilligan discloses a separate carrier adapter/holding device 110 with lengthwise walls and transverse walls, exterior robotic gripping surfaces and retaining structure holding labware 300 while the adapter is transported. Those walls correspond to the sidewall member, and the carrier-retaining frame corresponds to the adapter bracket. See Gilligan paras. [0080], and Fig. 17. Gilligan discloses grooves 370 extending through sidewalls of footprint 360, dimensioned to receive robotic gripper fingers 168. The groove's upper and lower surfaces restrain vertical slipping during robotic handling, and the interface is applicable to other labware. Gilligan teaches an adapter with sidewall grooves, finger dimensions and engagement which provides vertical restraint and reduced dropping, i.e., groove-and-gripper engagement technique. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to retain Toi's multiwell plate in Gilligan’s carrier adapter and provide the adapter's exterior gripping walls with Gilligan's gripper-engaging groove interface. Gilligan teaches vertical restraint to reduce slipping and dropping (see paras [0080] et seq.) The modification adds a plate transfer gripper of the type Gilligan identifies as robotic device 160, operating between liquid-handling steps, while retaining Hafner's positioning stage. This is the application of a known technique to a similar device ready for improvement, with the predictable result of more secure plate transport see, KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007); MPEP 2143(1)(C)-(D). One of ordinary skill in the art would have had a reasonable expectation of success because Gilligan’s frame already retains a carrier during movement and presents exterior grooves for mechanical restraint against vertical slip (see para [0080] et seq.) The expected result is a stabilized multiwell plate transported through robotic gripping engagement of a groove on the adapter sidewall.
Response to Arguments
Applicant’s arguments with respect to claim 1-11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure include:
a. Johnson et al., (US 4,952,518) which teach a machine for transferring liquids to and from the wells of assay trays in a controlled, automated manner and a solid phase assay tray for use with the machine. The machine includes a horizontally translatable table (15) that holds the tray (46), a plurality of liquid dispensing manifolds (54) for dispensing liquids into the tray wells (50) and an aspirating manifold (65) for aspirating liquid from the well. The dispensing and aspirating manifolds are mounted on a vertically translatable head (16) above the table.
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 between9:30am-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) 270-36383638. 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
Prosecution Insights