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 .
Election/Restrictions
Applicant's election with without traverse of Group II (claim 21) in the reply filed on July 29, 2026 is acknowledged. The instant examiner does not find Group I and II patentably distinct or a serious and/or examination burden. Thus, the restriction requirement as set forth in the Office action mailed on June 22, 2026 is hereby withdrawn and claim 21 is hereby rejoined and has been fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See MPEP § 804.01.
Claim Interpretation
In the patentability analysis of system claims, aspects or limitations Examiner interprets as functional are generally italicized whereas aspects interpreted as structural components are normally bolded. The bold font and italics are shown when the structure and function are initially introduced though not necessarily repeated, particularly in dependent claims. Examiner applies this formatting for both the examiner and applicant’s convenience. However, absent the referenced typestyles, the patentability analysis will still be clear regarding which limitations the examiner interprets as structural versus functional.
The claims are apparatus/device/system claims requiring only the recited structural components, although structured with physical features that can perform the stated functions or the intended uses. Functional limitations state either an intended use or operation, a manner of operating a device, apparatus or system, or what the apparatus/system does. Apparatus claims cover what a device is, not what a device does. Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). Also, a claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Of course, in the patentability analysis of these apparatus/system claims, functional features are not ignored and Applicant can and should employ such language where appropriate and helpful. However, if a prior art structure is capable of performing the intended use, or if such apparatus can operate in the manner described, then it meets the claim limitation (MPEP §§ 2114, 2173.05(g)).
In summary, while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997).
Examiner's referral to applicant's specification will generally pertain to the corresponding PG published application. 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.
Under the broadest reasonable interpretation, "contact-reducing structure" (claims 1, 11, 21) is construed consistently with the specification, which discloses this limitation generically as any structure that limits surface contact between the pipette tip and the major surface - including rod arrays (spec para. [0035]), overlapping plates (spec para. (0043]), hydrophobic coatings (spec para. [0039]), lotus-effect textures (spec para. [0040]), and even "saw tooth shaped structures, or periodic triangle shaped designs" (spec para. [0041]). The claim term is accordingly broad enough to read on any surface geometry or coating that reduces the contact area between the major surface and a pipette tip moving across it, and is not limited to the rod embodiment shown in the drawings.
Under the broadest reasonable interpretation, “major surface" (claims 1, 11, 21) is construed as the surface of the elongated body that extends from the upper first end to the lower second end and receives the pipette tip (spec para. [0034]); the claim does not require the major surface to be a single continuous plane, since the specification's own rod and overlapping-plate embodiments define the major surface by the combined top, exposed surfaces of discrete elements (spec para. (0035], spec para. [00431).
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.
Claims 10 and 20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 10 and 20 recite the major surface comprises an upper portion and a lower portion, wherein a slope angle of the upper portion is greater than a slope angle of the lower portion. However, these angles of the upper portion surface and lower portion of the major surface have not been established relative any axis/plane (e.g., horizontal, vertical) or any other structural limitation. The scope of these claims are confusing and indefinite.
Claim Rejections - 35 USC § 102/103
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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, 11 and 21 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as anticipated by Ballen et al., (US 20200386777 A1; hereinafter “Ballen”) or in the alternative, under 35 U.S.C. 103 as obvious over Ballen in view of Courtney et al., (US 20210316312).
Regarding claim 1 and claim 21, Ballen teaches a pipette (probe) tip disposal guide for an automated liquid handling system (an automated diagnostic analysis apparatus) and method of using the same, comprising:
“an elongated body having an upper first end and an opposite, lower second end and the second end configured to be positioned adjacent a pipette tip disposal.”
“a major surface extending between the first and second ends.” Ballen teaches that each guide rail includes a first section 704, second section 706 extending substantially orthogonal from first section 704, and a third section 708, the combined top edges of which form the surface across which the probe tip flange slides between the rails' first and second ends, corresponding to the claimed major surface. See para. [0043) and Fig. 7A. Ballen discloses that “a first end of the pair of guide rails 702 may be attached to an interior of waste chute housing 602” and that the rails are configured to transfer removed probe tips to a waste bin location,” which corresponds to the recited second end positioned adjacent the pipette tip disposal. See para. [0022] et seq.
“wherein the major surface comprises a contact-reducing structure.” Ballen discloses “a gap G1 between first section 704L and section 704R and a gap G2 between third section 708L and third section 708R should be sized to allow a bottom section (i.e., below the flange) of a probe tip to hang freely through gaps G1 and G2, as the bottom of the flange of the probe tip engages and slides on first section 704L and first section 704R of the pair of guide rails corresponds to the claimed “contact-reducing structure”. The rails contact the tip only at their narrow top edges and leave the bulk of the tip suspended in the gaps, exactly as the rod embodiment in applicant’s specification leaves the tip contacting only “the uppermost, rounded top portions” of the rods and not “the regions between the top portions”, see para [0044].
“wherein the major surface is configured to receive a pipette tip such that the pipette moves toward the lower second end to the pipette tip disposal with reduced contact with the pipette tip disposal guide.” Ballen discloses “the pair of guide rails 702, which may be sloped downward away from the guide plate, may be configured to transfer removed probe tips in the substantially upright position with their contaminated ends suspended freely without the risk of contacting or contaminating any surface as they move along the guide plate and pair of guide rails to a waste bin location.” Ballen’s stated purpose is to transfer tips “without any surface contact by the probe tip”. See abstract and para. [0022] et seq.)
However, if the paired guide rails in Ballen are not considered to disclose a single continuous “major surface”, then Courtney teaches a receiving element adapted to support an end of at least one pipette tip, the at least one pipette tip being toppled in use from the receiving element along a first direction. Specifically, Courtney discloses that “the receiving element comprises a planar portion” that “may be at an angle with respect to the horizontal plane” to “assists in the draining of fluid from the receiving element” and “encourages the pipette tips to fall along a particular direction.” See paras. [0012]-[0013].
It would have been obvious to one of ordinary skill in the art of automated liquid-handling waste disposal before the effective filing date of the claimed invention to combine Courtney's single, continuously sloped planar receiving surface with Ballen's rail-based contact-reduction technique substituting or supplementing Ballen's paired rails with a single inclined major surface bearing the same contact-reducing top-edge geometry. One of ordinary skill in the art would have a reasonable expectation of success because both references address the identical problem of guiding a used pipette/probe tip from a removal point to a disposal point while controlling its orientation and point of surface contact, and Courtney's own stated motivation (directing fall along a particular direction while assisting drainage, see para [0013] et seq.) is compatible with, and would predictably combine with, Ballen's stated goal of avoiding tip-to-surface contact.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found above.
Claims 2-8, 10, 12-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ballen and/or Courtney in view of Keller et al., (US 20190152713; hereinafter “Keller”)
Claims 2 and 12 recite a plurality of rods extending horizontally along the elongated body, wherein the contact-reducing structures, which are taught by Ballen for the reasons given above with respect to claims 1 and 11. Ballen's paired guide rails 702L/702R are themselves elongated rail members extending horizontally along the chute. Ballen does not explicitly teach a plurality of rods extending along the elongated body and the contact-reducing structure of the major surface is provided by portions of the plurality of rods. Keller teaches a driven roller conveyors using discrete cylindrical roller/rod elements 101 arranged transversely across the transport path each including a coating of PTFE (see para [0043] et seq.), because a series of discrete rod or roller elements, rather than a continuous surface, is a well-known technique in conveying and chute design for reducing frictional contact area between a moving article and the supporting structure. Furthermore, Keller recognizes the use of a hydrophobic coating on each of the rollers provides a roller that is resistive to chemicals, corrosion, and the like, so the roller can be used in the same environments as the traditional rollers, which would have been obvious to employ for transporting tips in the chemical analysis apparatus of Ballen.
It would have been obvious to one of ordinary skill in the art to modify Ballen's rail-based guide, or the Ballen/ Courtney combination above, to use Keller’s plurality of parallel rods in place of (or supplementing) the paired rails. One of ordinary skill in the art prior to the effective filing date of the claimed invention would have had a reasonable expectation of success because in the conveyor art discrete rod/roller elements were a known, interchangeable alternative for reducing surface contact along a sloped transport path in the same general mechanical field.
Regarding claims 3, 5, 6, 13, 15 and 16, as discussed above, with respect to claims 2 and 12, Keller teaches it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the contact-reducing surface of the Ballen/Coutney guide hydrophobic, applying Keller's known PTFE coated rollers. One of ordinary skill in the art would have had a reasonable expectation of success because Keller confirms PTFE's known low-adhesion surface properties and because forming or coating a component from an art-recognized material suited to its known purpose is a routine design choice. Furthermore, Ballen itself identifies residual-fluid adhesion and buildup on the chute surface as the precise problem to be solved.
Regarding claims 4 and 14, Ballen discloses a first end of the pair of guide rails 702 may be attached to an interior of waste chute housing 602. Ballen further discloses that each rail is fastened via mounting holes to the housing's “interior area 620.” This corresponds to the recited first and second side walls on which the rod/rail elements are mounted, on an outer side edge of the elongated body between its first and second ends. See para. [0034] -[0039].
Regarding claims 7 and 17, Ballen discloses that the probe tip's “bottom section (i.e., below the flange)" hangs "freely through gaps G1 and G2" between the rail sections while the flange slides on top (para. [0044] et seq.) While Ballen does not use the word "floor," the waste chute housing's receiving platform beneath the rails, which has "a downward slope extending from first side 606 to backstop 608," performs the function of the claimed floor, a surface below the rod/rail level toward which fluid draining from the tip and rails would flow, see para [0037]. This limitation rendered obvious over Ballen since a floor beneath a rod/rail array to catch and drain fluid being an obvious design choice for the reason that fluid should be able to "flow between the rods" and drain toward the disposal end.
Claims 8 and 18 recite a diameter of each of the plurality of rods is between 0.5 mm and 8 mm. Ballen's guide rail sections are dimensioned by width (11-17 mm) rather than a circular rod diameter (see para [0042] et seq.)The MPEP states in 716.02(d)(11) that to establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. The dimensions of the claimed guide rail sections are similar in magnitude (measured in millimeters) as taught in Ballen. In the absence of showing a criticality of the claimed rod/rail dimensions, it would have been obvious to one of ordinary skill the art prior to the effective filing date of the claimed invention to modify the rail/rod sections of Ballen based on factors such as overall desired footprint, pipette tip size, etc., through routine experimentation.
Claims 10 and 20, as best understood, recite the major surface comprises an upper portion and a lower portion, wherein a slope angle of the upper portion is greater than a slope angle of the lower portion (each angle is measured between the upper surface portion and lower surface portion compared to the horizonal axis/plane). Ballen teaches a two-stage sloped path, a probe tip eject device ramp 414 sloping downward at an angle of 3 to 8 degrees relative to the horizonal axis (see para [0033]). Ballen also teaches this ramp feeing into a pair of guide rails 702 sloped downward “at an angle ranging from 15 to 25 degrees” (relative to the horizontal axis). Although in Ballen the downstream (rail) section is steeper than the upper (ramp) section, which is the reverse ordering from the instant claim’s upper-steeper/lower-shallower arrangement, Ballen establishes that varying the slope angle between an upper transfer region and a lower guide region of a probe/pipette tip disposal path was already a known design variable in this exact field of art. Courtney separately discloses angling its receiving element to “assist in the draining of fluid…and thereby help to mitigate the risk of contamination” and to “encourage the pipette tips to fall along a particular direction, see para [0013]. This establishes that the slope angle is result-effective variable that a person of ordinary skill in the art would routinely optimize (including reversing which section is steeper) to control tip entry, drainage, etc., based on end user needs.
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Ballen and/or Courtney, as applied to claim 1 above, in further view of Nun et al., (US 20030147932; hereinafter “Nun”).
Ballen and/or Courtney do not explicitly disclose the structure of the major surface comprising a lotus effect structure. Nun discloses: "lotus-effect surfaces are extremely difficult to wet and have self-cleaning properties" attributable to "elevations of hydrophobic epicuticular wax which forms a rough or bumpy microstructure." See para. [0005] et seq. Nun further discloses that on such a surface "water forms droplets which roll off." See para. [0008]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply a lotus-effect microstructure taught by Nun to the contact-reducing surfaces of the Ballen/Courtney because Ballen itself identifies residual-fluid adhesion and buildup on the chute surface as the precise problem to be solved. The combination would had a reasonable expectation of success because Nun’s self-cleaning, non-wetting surface directly addresses residual-fluid buildup and adhesion, which is the exact failure mode Ballen identifies (see paras. (0019)-(0020)].
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.
Pertinent Prior Art
The following prior art is hereby made of record. Although the prior art is relied upon, the examiner considers the listed prior art relevant to the applicant’s invention and may be relied upon in a future prior art rejection or as general background information related to applicant’s field of endeavor.
a. Combs et al., (US 2022/0187331) teach As shown in FIG. 4, an embodiment of holding station 100 includes a top frame 102, a side box frame 150, a side cover panel 160 disposed over the side box frame 150, an upper waste chute 152 (which may be a lower portion of side box frame 150) connecting to a lower waste chute 162, and a waste chute cover panel 164 disposed over lower waste chute 162. Holding station 100 further includes a holding compartment 166 disposed below a portion of top frame 102. As noted above, waste container 220, indicated schematically by a box in FIG. 4, comprises a container positioned beneath waste chute 162 to receive waste items, such as pipette tips, falling through the chute 162. The waste container may be lined with a bag, typically disposable and plastic. As noted above, waste container 220 may be supported within instrument 225 in drawer 224 configured for lateral movement (e.g., fore and aft movement relative to a front of the instrument 225) between a first, or closed, position within the instrument 225 and a second, or open position, in which drawer 224 is pulled from the instrument 225 in a manner enabling access to waste container 220 so that the waste container can be removed from drawer 224 and emptied and/or a bag lining waste container 220 can be removed from the waste container 220 and replaced with a new, empty bag, see Fig. 4 and para [0119] et seq.
Conclusion
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 between 9:30am-7pm 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.
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/P. Kathryn Wright/Primary Examiner, Art Unit 1798
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