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 .
Response to Amendment
Applicant’s amendment filed on 11/14/25 has been entered. Claim 13 is cancelled. Claims 15-21 are withdrawn from consideration. Claims 1-12 remain pending and are examined herein.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 11/14/25 is acknowledged.
Claim Objections
Claim 5 objected to because of the following informalities: “though tubing” should be “through tubing”. Appropriate correction is required.
Claim Interpretation
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 following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(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) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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: micro-displacement hydraulic controller and macro-displacement hydraulic controller in claim 1; and internal sealing assembly in claim 4.
Applicant discloses the micro-displacement controller comprises an internal sealing assembly, a piston-style actuator, and a fluid connector to connect the controller to a fluid line (The micro-displacement hydraulic controller can comprise an internal sealing assembly, a piston-style actuator (such as a threaded rod), and a fluid connector to connect the controller to a fluid line. Para. [0052]).
Applicant discloses the macro-displacement controller comprises a housing, an internal sealing assembly, a piston-style actuator, gaskets to prevent fluid leakage, and screws to hold the assembled controller together (The macro-displacement hydraulic controller can comprise a housing, an internal sealing assembly, a piston-style actuator, gaskets to prevent fluid leakage, and screws to hold the assembled controller together. Para. [0053]).
Applicant discloses the internal sealing assembly comprises housing and screws (para. [0109]).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., 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) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
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.
Claim(s) 1-6, 8, 9, 11, 12, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Endo (US 4749270 A) as cited in previous Office Action in view of El-Badry (Micromanipulators and Micromanipulation, 1963).
Regarding claim 1 and 4, Endo discloses a bio-manipulator (Fig. 2), comprising:
a displacement hydraulic controller (joystick of Fig 2 and 9 (also known as hydraulic operator 26, Fig. 9) connected to the hydraulic drive mechanism 17 in Fig. 2, 6 and 7;) comprising a housing (hard rest 60, Fig. 9), an internal sealing assembly comprising a sealing assembly housing (housing surrounded the piston rod 45, Fig. 7 and a screw (the piston rod is securely secured by screws, secured to the piston rod 45 by a set screw. Col. 8, ln 38-39), a piston-style actuator (piston rod 45, Fig. 7), and screws to hold the assembled controller together (screw 12b, Fig. 6 and 7);
a junction box (28 and 30, Fig 12, along with portion of holder 35 above transparent disc 75 extending to connection with tube 19, "annular support frame 28", col 4 In 25, and "feed frame 33", col 4 In 30-31), wherein a portion of the junction box is optically transparent ("FIGS. 11 and 12 show another form of needle carrier 15A. Instead of being carried by the holder frame 33 as shown in FIGS. 4 and 5, in this instance, a transparent disc 75 is fitted in the feed frame 30", col 9 In 54-57);
an extrusion head (portion of holder 35 below transparent disc 75, Fig 11; "holder 35", col 9 In 60) in fluidic communication with the junction box (portion of holder 35 above transparent disc 75 and portion of holder 35 below transparent disc 75 are in fluid communication to allow fluid from tube 19 to provide pressure for glass needle), displacement controller ("Accordingly, it is possible to oscillate the joystick 70 within the slot 60a in a direction indicated by a double-ended arrow B about the articulation member, thus causing the slider 66 to slide in either of the directions indicated by the arrow A, acting through the ball 66a." col 8 In 10-15; "The other end of the piston rod 65 is connected to the slider 66 which is slidable on the base 59 in the horizontal direction, as indicated by a double-ended arrow A" col 7 In 61-64; see fig 10; see fig 10, piston rod 65 is fluidly coupled with hydraulic drive mechanism 17 which communicates with holder 35 through support frame 28), and macro-hydraulic controller("so that the rotation of the knob 74 causes an axial movement of the piston rod 73." col 8 In 24-26, piston rod 73 is fluidly coupled with hydraulic drive mechanism 17 which communicates with holder 35 through support frame 28); and
an adapter (12a, Fig 2; "dovetail 12a") configured to mechanically couple the extrusion head to the optical axis of a microscope ("a stage 12 is detachably mounted relative to the body 10 through a translational structure including a dovetail 12a and a dovetail groove 10a" col 3 In 52-54, Stage 12 includes holder 35 and body 10 is a microscope, "As shown, the microscope includes a body 10," col 3 In 47 -48. The translational structure is designed to move the extrusion head to the optical axis of the microscope, "The glass needle is carried by an annular needle holder in the direction of the optical axis" col 2 In 56-58).
The embodiments of Endo only show a configuration with one hydraulic controller instead of two. Furthermore, Endo does not explicitly disclose hydraulic controller of Endo comprises a gasket to prevent fluid leakage.
Regarding installing a gasket in the hydraulic controller, El-Badry discloses it is typical for capillaries/cylinders to be inserted into a holder/housing firmly and sealed by means of rubber gasket (A long polyethylene tubing of about O.4-mm internal diameter connects the microinjector to an angle-type micropipet holder designed for use with the micromanipulator. Capillaries inserted in the holder are firmly sealed by means of neoprene rubber gaskets. The microinjection unit may be used separately, and the holder may be, page 65, para. 4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have utilized gasket to firmly secured the cylinders (cylinders 41, Fig. 7) inside of hydraulic controller of Endo as taught by El-Badry. Doing so allows the components of device be securely sealed inside the housing of the controller.
Regarding having a second displacement hydraulic controller, Endo discloses the device can be further modified with multiple hydraulic drive mechanism connected together (Col. 2, ln 61-66). It would have been obvious to one of ordinary skill in the art before the effective filing date to have incorporated a second hydraulic controller as taught by Endo. Doing so may simplifying the construction of interlocked mechanism, and with consequent increase in the level or reliability and durability of apparatus (Col. 2, ln 61-66).
Regarding claim 2, Modified Endo discloses the claimed invention as discussed above in claim 1. Endo discloses the extrusion head further comprises an adapter configured to receive interchangeable tip (clamp screw 36, Fig 12; "having a clamp screw 36 which is used to secure the glass needle 16" col 4 In 35-36).
Regarding claim 3, Modified Endo discloses the claimed invention as discussed above in claim 2. Endo discloses the adapter configured to receive interchangeable tips is a tapered nozzle (see fig 5, clamp screw 36 is shown to be in the shape of a nozzle with a tapered end) configured to receive micropipette tips, a tapered nozzle with an orifice configured to receive a glass capillary, or a sealed adapter configured to receive a luer-lock syringe needle (clamp screws are capable of receiving and securing any of the above devices).
Regarding claim 5-6 and 9, Modified Endo discloses the claimed invention as discussed above in claim 1. Endo discloses the two displacement hydraulic controllers (after modification as discussed above in claim 1) are in fluidic communication with the junction box through tubing (hydraulic transmission tube 25 and 27; Fig 3) filled with a first fluid, wherein the first fluid is a non-biocompatible fluid (oil, col. 6, ln 12-26), and
The extrusion head and junction box are in fluidic communication through tubing filled with a second fluid (col. 5, ln 4-23), where in the second fluid different than the first fluid (liquid chemical; col. 5, ln 15-23), wherein the second fluid is a bio-compatible fluid (the liquid chemical is being deposited to the stage of the microscope station, and therefore, it needs to be bio-compatible to the biological sample being analyzed).
Regarding claim 8, Modified Endo discloses the claimed invention as discussed above in claim 5. Endo discloses the second fluid forms an immiscible layer with the first fluid in the junction box (whereby by filling the tube 19 with a silicone oil or the like, pressure can be applied to a liquid chemical contained within the glass needle 16 to displace it from the needle tip. col. 5, ln 15-23; the silicone oil in the tube is used to push the liquid chemical out to the stage, which can only work if the two fluids are immiscible).
Regarding claim 11, Modified Endo discloses the claimed invention as discussed above in claim 1. Endo discloses the hydraulic controllers comprise threaded shaft (threaded shaft 55, Fig. 8). Endo is silent on the threaded shaft of one of the hydraulic controllers has a larger diameter than the other.
In an analogous art, El-Badry discloses a micromanipulator (Fig. 13, page 40) comprising two pistons (two perpendicularly intersected piston on the left-hand side of Fig. 13), wherein the one of the pistons have a larger diameter than the other (Operation depends on the displacement of hydraulic fluid by one of the two pistons. The larger piston, the coarse volumetric control, has a diameter of about 0.4 mm, while the smaller piston, providing fine displacement, is about 0.125 mm in diameter. Page 40, para. 1). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the two hydraulic controllers of the device of Modified Endo based on the design of El-Badry to derive the claimed invention. Having two controllers with different piston diameters allows the operator a more delicate control to volume displacement of the fluid (The larger piston, the coarse volumetric control, has a diameter of about 0.4 mm, while the smaller piston, providing fine displacement. Page 40, para. 1).
Regarding claim 12, Modified Endo discloses the claimed invention as discussed above in claim 11. Neither Endo nor El-Badry explicitly discloses the threaded rods specification for the macro-displacement hydraulic controller.
As the displaced volumes of fluid are variables that can be modified, among others, by adjusting the diameter of the piston rod, with volume displaced both increasing as the rod diameter is increased, the precise rod diameter would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed rod diameter cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the rod diameter in the Endo to obtain the desired balance between displaced volume as taught by El-Badry (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Regarding claim 14, Modified Endo discloses the claimed invention as discussed above in claim 1. Endo discloses each hydraulic controller comprises a dial (coarse motion knob 74, Fig. 2) capable of being operated independently of the other
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Endo in view of El-Badry as applied to claim 5 above, and further in view of Walsh (Formation of droplet interface bilayers in a Teflon tube, 2016).
Regarding claim 7, Modified Endo discloses the claimed invention as discussed above in claim 5. Neither Endo nor El-Badry specifically discloses the first fluid is Novec-7500.
In an analogous art, Walsh discloses gas in the tubing system is problematic as it is compressible and therefore when the syringe pump starts/stops the fluid motion in the tube does not start/stop as rapidly as when no gas is present (in the context of Modified Endo, this may interfere with precise amount of fluid being displaced). To reduce/minimize bubble formation, fluorocarbon with low viscosity/partial pressure such as HFE 7500/Novec-7500 can be utilized (Forming fluidic architectures, para. 1). Therefore, it would have been obvious to one of ordinary skill in the art to have considered and adopted Novec-7500 as the first fluid in order to reduce/minimize unwanted bubble formation (Walsh, Forming fluidic architectures, para. 1).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Endo in view of El-Badry as applied to claim 5 above, and further in view of Doe (Generating CRISPR/Cas9-Derived Mutant Mice by Zygote Cytoplasmic Injection Using an Automatic Microinjector, 2018).
Regarding claim 10, Modified Endo discloses the claimed invention as discussed above in claim 5. Neither Endo nor El-Badry specifically discloses the second fluid is PBS.
Phosphate buffered saline (PBS) are generally used for analyzing or preserving the cellular/biological sample under microscope. In an analogous art, Doe discloses PBS are used for storing the cellular sample (3.1, Zygote Preparation, step 4; Fig. 4).
Therefore, it would have been an obvious to on of ordinary skill in the art before the effective filing date to have utilize liquid chemicals such as PBS as the second fluid for application of analyzing cellular sample using microscope and micromanipulators as demonstrated by art like Doe.
Conclusion
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/M.H./ Examiner, Art Unit 1758
/MARIS R KESSEL/ Supervisory Patent Examiner, Art Unit 1758