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 .
Claim Objections
Claim 8 is objected to because of the following informalities: it is believed that “the base tip and the sub tip include resin” in line 2 should read “the base tip and the sub-tip comprises of resin”. 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:
“mechanism configured to generate a suction force” in claim 11;
“transfer mechanism configured to move the head” in claim 11.
The specification teaches a structure of the mechanism configured to generate a suction force through a piston mechanism using a suction pump, a plunger, or the like can be used.
The specification teaches a structure of the transfer mechanism configured to move the head through an X-axis, Y-axis, and Z-axis motor.
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 § 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 1-12 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 recites the limitation “the suction port has a size smaller than a size of the distal end opening”. It is unclear whether this refers to cross-sectional area of the suction port and distal end opening or another dimensional measure (i.e. length).
Claim 12 recites the limitation “a stock part configured to stock”. It is unclear whether “a stock part” refers to a structure used for stocking the base tip or another structural feature related to the part itself.
Claims 2-12 are indefinite because they depend on claim 1.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, 6, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gehrig et al. (US 10058859).
Regarding claim 1, Gehrig et al. teaches a suction tip device configured to suck a biological subject (Column 1, para. 5 “for example the cells of a microtiter plate”), the suction tip comprising a base tip (see annotated Figure 6 below) including a distal end opening (Figure 6, feature 7 coupling point), a sub-tip (Figure 6, feature 2 pipette tip) including a suction port (Figure 6, feature 3 deformable expulsion end) configured to suck the biological subject, and a guide passage (see annotated figure below) having one connected to the suction port and another end that receives the distal end portion of the base tip (Figure 6, feature 2 pipette tip); wherein the base tip and sub-tip are coupled and integrated by externally fitting the other end of the guide passage to the distal end portion (Figure 3, feature 2 pipette tip and 7 coupling point), the integration configuring one suction path in which the tubular passage and the guide passage communicate with each other (Col 6, 15-20, “the coupling point 7 is inserted into the open upper end of the pipette tip 2 in order to couple the pipette tip 2 held ready in a holder or supporting frame 16”); and the suction port has a size smaller than a size of the distal end opening (Figure 6, feature 3 deformable expulsion end and 7 coupling point – the annotated figure below clearly shows the suction port has a smaller size (i.e. diameter) than distal end opening).
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Regarding claim 3, Gehrig et al. teaches a suction tip wherein in a state where the base tip and the sub-tip are coupled and integrated (Col 6, 15-20, “the coupling point 7 is inserted into the open upper end of the pipette tip 2 in order to couple the pipette tip 2 held ready in a holder or supporting frame 16”), the distal end portion has an outer peripheral surface in close contact with an inner peripheral surface of the other end of the guide passage (Figure 3, feature 2 and 7).
Regarding claim 6, Gehrig et al. teaches a suction tip wherein the sub-tip includes a first stopper part (Figure 2, feature 2 pipette tip) configured to position the guide passage in an extending direction (Col 9, 10-12, “Fig. 3 shows the situation in the pipette tip take up position. The pipette tip 2 is hung in the supporting frame 16”). The annotated Figure 2 below shows a first stopper part present on the sub-tip.
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Regarding claim 10, Gehrig et al. teaches a suction tip further comprising a plunger (Figure 6, feature 8 displacement unit) that is slidably accommodated in the tubular passage of the base tip (Col 6, 19-21 “The pipette unit 1 has a displacement unit 8 fluidically connected to the coupling point 7 and the pipette tip 2 mounted thereon”), and generates a negative pressure at the suction port (Col 6, 23-27 “It is essential that the displacement unit 8 can generate in the coupled pipette tip 2 a negative pressure”).
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 2, 4, 5 are rejected under 35 U.S.C. 103 as being unpatentable over Gehrig et al. (US 10058859) as applied in claim 1 above further in view of Mathus et al. (US 9,333,500).
Regarding claim 2, Gehrig et al. teaches a suction tip with a base tip (Figure 6, feature 7 coupling point). Gehrig et al. also teaches that the suction port with a second distal end portion (Figure 6 feature 3 resiliently deformable expulsion end) are generally round in shape (Col 3, 35-37). Gehrig et al. does not explicitly teach that the first distal end portion (“distal end” in annotated Figure 6 above) of the base tip has a circular cross section. However, Mathus teaches a base tip (feature 12) with a lower section (232) with a circular cross-section (Figure 14, feature 233 lowermost portion). Mathus also teaches that cylindrical mounting shafts and cylindrical tip collars lessens mounting and ejection forces (Col 2, 5-7).
It would have been obvious to a person of ordinary skill in the art to use the Mathus et al. configuration in Gehrig et al.’s device with a reasonable expectation that it would have a positive effect on lessening mounting and ejection forces on the pipette tip. This method of improving Gehrig et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Mathus et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Gehrig et al. and Mathus et al. to obtain the invention as specified in claim 2.
Gehrig et al. teaches a suction port with first and second distal end portion. Gehrig et al. does not explicitly teach the second distal end portion has an outer diameter smaller than the first distal end portion. However, Mathus et al. teaches a pipette tip (feature 14) with a second distal end portion (feature 44) with a smaller diameter than the first distal end portion (feature 42). Mathus et al. teaches that pipette tips are generally conical in shape (Col 1, Line 46), while the small opening allows the liquid sample to be received into and dispensed from the barrel of the pipette tip (Col 1, 51-53).
It would have been obvious to a person of ordinary skill in the art to use the Mathus et al. configuration in Gehrig et al.’s device with a reasonable expectation that it
would have a positive effect on receiving and dispensing from the barrel of the pipette tip. This method of improving Gehrig et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Mathus et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Gehrig et al. and Mathus et al. to obtain the invention as specified in claim 2.
Regarding claim 4, Gehrig et al. teaches a distal end portion (feature 7) that has an outer peripheral surface, and the guide passage of the pipette tip (feature 2) has an inner peripheral surface. Gehrig et al. teaches that these two surfaces are in close contact (Figure 1, feature 2 and 7). Gehrig does not explicitly teach that the outer peripheral surface is a tapered surface, whose outer diameter decreases towards the distal end opening. Gehrig also does not explicitly teach that the inner peripheral surface is a tapered surface, whose inner diameter decreases towards the suction port. However, Mathus et al. teaches a mounting shaft (feature 12) with a sealing section (feature 32) whose outer peripheral surface tapers towards the distal end opening with a decreasing outer diameter. Mathus et al. teaches a sealing area (feature 39) whose inner peripheral surface tapers towards the suction port with a decreasing inner diameter. Mathus et al. also teaches that the fit between the mounting shaft and the disposable tip is achieved by pushing the tapered mounting shaft into the tapered pipette tip collar until it wedges into the tip (Col 1, 58-61).
It would have been obvious to a person of ordinary skill in the art to use the Mathus et al. configuration in Gehrig et al.’s device with a reasonable expectation that it
would have a positive effect on ensuring a fit between the distal end portion and guide passage. This method of improving Gehrig et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Mathus et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Gehrig et al. and Mathus et al. to obtain the invention as specified in claim 4.
Regarding claim 5, Gehrig et al. teaches a pipette tip (feature 2) with a leading surface continuously at the other end of the guide passage (Col 6, 14-15 “The pipette tip 2 is thus fitted onto the coupling point 7 formed by the pipette shaft”). Gehrig et al. does not explicitly teach that the leading surface is tapered. However, Mathus et al. teaches a leading tapered surface in pipette tip (feature 14) along the inside collar (feature 36). Mathus et al. teaches that disposable pipette tips have historically relied on tapered fits between the mounting shaft and the pipette tip collar to secure and seal the tips to the mounting shaft (Col 1, 54-59).
It would have been obvious to a person of ordinary skill in the art to use the Mathus et al. configuration in Gehrig et al.’s device with a reasonable expectation that it
would have a positive effect on securing and sealing the base tip to the guide passage. This method of improving Gehrig et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Mathus et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Gehrig et al. and Mathus et al. to obtain the invention as specified in claim 5.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Gehrig et al. (US 10058859) as applied in claim 1 above further in view Ott et al. (US 12415180).
Regarding claim 7, Gehrig et al. teaches a suction tip with a base tip. Gehrig et al. does not teach the base tip includes a second stopper part. However, Ott et al. teaches a pipette tip (feature 14) with a base tip including a collar (feature 16). Ott et al. teaches that “the collar (16) prevents a deformation of the pipette tip 14 during attachment to the pipette 23 and provides a stabilizing effect” (Col 15, 19-22).
It would have been obvious to a person of ordinary skill in the art to use the Ott et al.’s configuration in Gehrig et al.’s device with a reasonable expectation that it
would have a positive effect on preventing deformation of the base tip and improving stabilization. This method of improving Gehrig et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Ott et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Gehrig et al. and Ott et al. to obtain the invention as specified in claim 7.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Gehrig et al. (US 10058859) in view of Petrek (US 8524170).
Regarding claim 8, Gehrig et al. teaches a sub-tip that comprises of resin in the resiliently deformable expulsion end (feature 3) (Col 3, 29-31 “typical materials for a resiliently deformable expulsion end of the pipette tip include polyimide, polyamide, or silicone). Gehrig et al. does not teach explicitly whether the base tip comprises of resin. However, Petrek teaches a mount segment (feature 412) may be molded from either polypropylene or another polymer (Col 8, 18-19). Petrek also teaches that thermoplastic elastomers that are softer than polypropylene or polyethylene may be used for the mount segment (feature 412), thereby reducing force required to mount of eject the sealing tip (feature 410) from the pipette (feature 110) (Col 8, 26-29).
It would have been obvious to a person of ordinary skill in the art to use the Petrek’s configuration in Gehrig et al.’s device with a reasonable expectation that it would have a positive effect on reducing force required for mounting and ejection. This method of improving Gehrig et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Petrek. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Gehrig et al. and Petrek to obtain the invention as specified in claim 8.
Gehrig et al. teaches an insertion fitting between the distal end portion of the base tip (feature 7) and the guide passage of the sub tip (feature 2). Gehrig et al. does not teach explicitly that the distal end portion of the base tip is inserted into the other end of the guide passage without interposing an adhesive. Petrek teaches an insertion fitting between the base tip and the guide passage of the sub tip (Col 11, 7-12 “As shown in FIG. 10 a relatively tight friction fit between an interior surface 920 of the liquid handling segment 914 and an exterior surface 922 of the mount segment 912 is sufficient to hold the parts together, to maintain an air-tight seal between the mount segment 912 and the liquid handling segment 914”). Petrek teaches that simple friction fits for disposable tips are known in the art, providing an air tight seal between the shaft and the tip (Col 1, 48-54).
It would have been obvious to a person of ordinary skill in the art to use the Petrek’s configuration in Gehrig et al.’s device with a reasonable expectation that it would have a positive effect on maintaining an airtight seal between base and sub tip. This method of improving Gehrig et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Petrek. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Gehrig et al. and Petrek to obtain the invention as specified in claim 8.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Gehrig et al. (US 10058859) in view of Petrek (US 8524170) as applied in claim 8 above, in further view of Mathus et al. (US 7662343).
Gehrig et al. teaches a sub-tip that comprises of resin in the resiliently deformable expulsion end (feature 3) (Col 3, 29-31 “typical materials for a resiliently deformable expulsion end of the pipette tip include polyimide, polyamide, or silicone).
Gehrig et al. does not teach explicitly whether the base tip and sub-tip are made of resin of a same material. However, Mathus et al. teaches a device using a disposable pipette tip (feature 14) and pipette mounting shaft (feature 12); pipette tips (feature 14) manufactured in accordance with the invention will be typically made of molded plastic, normally polyethylene or polypropylene with or without various additives (Col 6, 60-63); the mounting shaft (feature 12) is preferably made from machined steel or machined or molded from chemically resistant plastic such as PEEK or polypropylene (Col 7, 52-54).
It would have been obvious to a person of ordinary skill in the art to use the Mathus et al.’s teaching in Gehrig et al.’s device with a reasonable expectation of the benefits from using polyethylene as a base and sub-tip, such as chemical resistance. This method of improving Gehrig et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Mathus et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Gehrig et al. and Mathus et al. to obtain the invention as specified in claim 9.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Gehrig et al. (US 10058859) in view of Scherr et al. (US 20200338552 A1).
Regarding claim 11, Gehrig et al. teaches a biological transfer device comprising a head (feature 18) to which the suction tip is attached, which includes a mechanism configured to generate a suction force and a discharge force at the suction port (feature 6 and 17). Gehrig et al. does not explicitly teach a transfer mechanism configured to move the head horizontally and move the head up and down, specifically via motors. However, Scherr et al. teaches a 3-axis servocontrolled motor in their dispensing syringe embodiment (Figure 2D). Scherr et al. also teaches that this embodiment benefits process throughput and enables parallel processing of one or more cells prepared and stored in a microtiter plate (para. 0077).
It would have been obvious to a person of ordinary skill in the art to use the Scherr et al.’s teaching in Gehrig et al.’s device with a reasonable expectation that it would have positive effect on enabling parallel processing and increasing processing throughput. This method of improving Gehrig et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Scherr. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Gehrig et al. and Scherr et al. to obtain the invention as specified in claim 11.
Regarding claim 12, Gehrig et al. teaches a biological subject transfer device further comprising a stock part (supporting frame 16) configured to stock, in a state where the tubular passage faces upward, a sub-tip (Col 6, Line 15-18 “the coupling point 7 is inserted into the open upper end of the pipette tip 2 in order to couple the pipette tip 2 held ready in a holder or supporting frame 16”). Gehrig et al. also teaches a controller (feature 6) configured to control the transfer mechanism (feature 4) so as to externally fit, at the stock part, the sub-tip to a distal end portion of the base tip. Gehrig et al. does not teach stocking the base tip to which the sub tip is attached. Nonetheless, it has been held that rearrangement of parts is unpatentable because shifting of parts would not modify the operation of the device (MPEP § 2144.04 VI). Modifying the device of Gehrig et al. such that the base tip was stocked with the sub-tip instead of stocking only the sub-tip only would amount to merely rearrangement of parts, as such a modification would predictably result in communication between the plunger, base tip, and sub-tip to occur still.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIUS FRANCIS YOH whose telephone number is (571)272-3489. The examiner can normally be reached Monday-Friday: 7:30-5 PM.
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/JULIUS FRANCIS YOH/Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799