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 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:
A unit for holding…and being shaped to allow...as in cl. 7
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.
Unclear from the disclosure.
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.
Claim 4 is 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 4 recites the limitation "the connecting wall”. There is insufficient antecedent basis for this limitation in the claim.
It appears that Applicant intends to recite “a first connecting wall.”
Claim 4 further recites the limitation “the fixed magnet being mounted..” in which the recitation lacks proper antecedent basis in the claims and it is unclear what magnet is sought to be structurally arranged as claimed wherein claim 1 provides for “at least one magnet mounted fixedly to the securing portion.”
Claim 4 further recites “the other wraparound wall” that lacks proper antecedent basis in the claims. It appears that Applicant intends to recite “another one of said at least one wraparound walls comprising an end wall.”
Claim 7 is 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.
The metes and bounds of claim 7 and the sought functionality of the unit are indefinitely set forth.
The recitation “…for holding the magnetic portion, the securing portion…” is not clearly provided in what holding functionality is intended with respect to the recitation “the securing portion.”
Does Applicant intend to recite that the unit is for holding the magnetic portion and the securing portion?
Further, as discussed above, a unit for holding…and being shaped to allow...is given as an alternative-type “means for” recitation that is not recited with sufficient structure to the recited functionality and wherein the specification does not make clear the corresponding structure and equivalents thereof.
Claim 13 is 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.
The metes and bounds of the sought system by claim 13 are indefinitely defined herein.
Claim 13 sets froth the added element of a plate as claimed, however, its structural and/or functional relationship within the confines of the system is/are indefinitely set forth.
What is the relation of the added element of this plate to the confines/other constituent elements of the system?
Claim 14 is 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.
The metes and bounds of the sought methodology that provides for “using the system” as in claim 14 are indefinitely defined herein.
It is unclear if the sole active step of “moving sampler cones…” constitutes the sought using of the system as in claim 14. Applicant should make clear the active, positive steps that afford extracting components from a sample. From Applicant’s disclosure, it does not appear that the movement of the pipette cones against the magnetic portion alone provides for extracting components in and of itself.
See MPEP 2173.05(q).
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.
Claim(s) 1-6, 8-10, and 14 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Alix et al. (US 2019/0316114), hereafter Alix.
Alix discloses a system for extracting components from a biological sample (abstract, [0002]) comprising at least: an extraction platform [0108] (base 34),
a magnetic extracting module [0112] comprising a magnetic portion 16 [Fig. 7] and a securing portion 38 (and as in a housing 38 for receiving the extraction module in cl. 3; par.[0108] fig. 3A, for example) for securing the module to the extraction platform [0095,0113],Fig. 7], said magnetic portion comprising at least one magnet fixedly mounted relative to said securing portion [0112] (at least one permanent magnet 72, fig. 7), the extraction platform comprising a pipetting support configured to interact with a pipetting device [0108] (the mobile part 36 as in the "pipette support"), characterized in that the magnetic portion of the magnetic extracting module has at least one operating position in which the magnetic portion is fixed at least with respect to the pipetting support/pipetting stand [Fig. 12-13] or [0109] (at least one position in which the tips 21 do not dip into the wells, and are at a distance from the latter so as to allow the well supports to be handled by the user and magnetic particles to be captured in a central position of the cones 20). This is likewise seen in claim 14 to the likewise physical arrangement to claim 1 and wherein Alix discloses a step of moving sampler cones of the pipette against the magnetic portion of the extraction module (pars.[0061,0109-0114], for example). With regard to claim 2, Alix discloses that the pipetting device comprises at least one sampler cone, the magnetic portion of the extraction module is fixed at least in the operating position (see figs. 1, 12, and 13, and accompanying disclosure); Examiner further asserts that the pipetting device is not a positively claimed element necessitated by the claims and is drawn to a prospective workpiece (“a pipetting support…configured to cooperate with a pipetting device”). With regard to claim 4, as best understood herein, Alix discloses the housing comprising at least two wraparound walls to wrap around the extraction platform one of the walls called a connecting wall carrying the magnetic portion, the fixe magnet being mounted so as to project relative to the connecting wall, the other wraparound wall being called the end wall (see wall coinciding item ‘78’ wherein the fixed magnet 72 of the magnetic portion 16 is held and protrudes) and an end wall being a wall opposite thereto on an opposing side of the housing (see fig. 3A, figs. 12A). With regard to claim 5, the securing portion 38 comprises a body of which one face is shaped to be in contact with the extraction platform, in which one face as in Alix is commensurately shaped in as much as claimed and thus provides a commensurate shaping fully capable of being in contact with the extract module as claimed. With regard to claim 6, Alix discloses that the magnetic portion 16 is mounted removably relative to the securing portion (figs. 3A, 12A in which the magnetic portion 17 is fully able to be inserted and removed therefrom the securing portions as through the mounting slot 78 of the securing portion; see also pars.[0062,0069] and second/third housings for removably mounting). With regard to claim 8, Alix discloses that the pipetting device comprises an electronic pipette 12 and a pipette holder 14 (pars.[0064,0104,0108], fig. 1, 7, for example). With regard to claim 9, Alix provides that the module is fixed to the pipetting support by the securing portion (figs. 1, 12, 13), and further, wherein the recitation is drawn to a process recitation not afforded patentable weight in a device claim. With regard to claim 10, Alix discloses the extraction module comprises at least one bar 76 comprising the at least one magnet (fig. 1, 7). With regard to claim 13, Alix discloses a plate
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) 7 and 13, as best understood herein, is/are rejected under 35 U.S.C. 103 as being unpatentable over Alix in view of Schacher et al. (US 2008/0063567), hereafter Schacher.
Alix has been discussed above.
Alix does not specifically disclose a unit as recited in claim 8, and a plate as in cl. 13.
Schacher discloses an automated analyzer with automatically actuated movable closure of pipetting openings comprising a conveyor 91 as in a circular plate that is movably mounted in such a way that it can be moved in translation and/or rotation, and a unit for holding the magnet 33 with a securing portion by way of screws on lower plate 33 of the transport device 31, such unit being shaped to allow relative movement with respect to the securing portion in as much as claimed as the unit is commensurately shaped as claimed (pars.[0042,0064], figs. 1, 2, 15, for example).
It would have been obvious to one of ordinary skill in the art to modify Alix to provide a unit as recited in claim 8, and a plate as in cl. 13 such as suggested by the analogous prior art of Schacher to an automated analyzer with automatically actuated movement of pipettors provides a protective cover to the magnet and while affording rotatable movement of on-board reagent/sample holders to be selectively moved into place for desired pipetting and assay initiation.
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alix in view of EP2110670, hereafter Tajima.
Alix has been discussed above.
Alix does not specifically disclose a set of at least two bars each bar comprising at least one magnet as recited in claim 11, and comprising a cross-member for securing each bar as in cl. 12.
Tajima discloses a magnetic particle processing system comprising a plurality of magnets 139 and at least two bars 141 each bar comprising at least one magnet the at least two bars being arranged parallel to and spaced apart from each other so as to allow the passage of a row of pipette cones, and comprising a cross-member 137 for securing each bar (par.[0098], fig. 9).
It would have been obvious to one of ordinary skill in the art to modify Alix to include disclose a set of at least two bars each bar comprising at least one magnet as recited in claim 11, and comprising a cross-member for securing each bar as in cl. 12 such as suggested by the analogous prior art of Tajima to a magnetic particle processing system in order to afford a substantial and dynamic magnetic support that also affords movable functionality for access to the various dispensing tips and such that a magnetic field can be applied to the interior of all the dispensing tips.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 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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/NEIL N TURK/Primary Examiner, Art Unit 1798