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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the system comprising a second plunger (all of the elements as provided for claims 16 and 19), and the first channel coaxial to second channel surrounding the first channel, coaxial wall…(all of the elements as provided for claim 18) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Such features do not appear to be labeled nor indicated by any reference numbers.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
A claim is only limited by positively claimed elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”. MPEP 2115 Material or Article Worked Upon by Apparatus.
It is noted that the although the apparatus claim 1 mentions a liquid, no liquid is positively claimed as an element of the invention.
It is presumed that the phrase “each channel” refers to “each of the multiple channels”; “each well” refers to “each of the multiple wells”; and “each protrusion” refers to “each of the multiple protrusions”. Therefore, the claims should employ consistent language to refer to the same structures. See all claims reciting the respective phrases.
It is noted that the term “align” is relatively broad. There claims do not specifically define what is structurally required by the term. Any two structures from which a straight line can be drawn between can be considered as aligned.
It is noted that the “when” clauses of apparatus claims 6, 10, and 20 are directed to conditions that are never required to occur, be performed. If applicant intends to claim require the well plate to located in the chamber such that the multiple wells are align with respective corresponding channels of the multiple channels, then the claims should clearly recite such.
It is noted that phrase “biological assay reagent” is not limited to nor defined in the claims as being any specific liquid. The phrase is directed to intended use of the liquid.
Claim Rejections - 35 USC § 112
Claims 1-14 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.
As to claim 1, it is unclear what is the nexus of “a respective channel” in the 2nd and 3rd paragraphs to the previously recited multiple channels because the claim does not clearly recite such.
Therefore, it is also unclear which/what respective channel is being referenced by “the respective channel” in last paragraph. Also applicable to claim 5.
Claim 1 recites the limitation "the aligned well" in last line. There is insufficient antecedent basis for this limitation in the claim. No well of the mulitiple wells of the well plate has been previously claimed as being aligned with anything.
Furthermore, it is noted that “movement” is not a structural element. There is no requirement for any process step of any moving of the plunger nor anything else of the claimed dispensing system to be moved.
Claims 2-14 are rejected via dependency upon a rejected claim.
As to claims 7-10 and 12 it is unclear what/which channel is being referenced by the phrases “the channel” and “the channels” because claim 1 previously recites “multiple channels”. Therefore, it is unclear what is the nexus of “the channel” and “the channels” to the “multiple channels”.
Claim 7 recites the limitation "the surface tension" in the last paragraph. There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is noted that “a respective amount of liquid” is not required to be the same liquid mentioned in claim 1 and each well is not required to contain the same liquid. This is also applicable to claim 8.
As to claim 8, it is unclear what is the nexus of “a channel” to the prior recited “multiple channels” because the claim does not provide for such. Therefore, it is also unclear what/which channel is being referenced by “the channel”.
As to claim 10, it is unclear what/which protrusion is being referenced by “the protrusion” because claim 1 recites “multiple protrusions”.
Claim 19 recites the limitation "the hole of the first plunger" in the last paragraph. There is insufficient antecedent basis for this limitation in the claim. The first plunger has not been previously claimed as comprising a hole.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-3, 5-8, 15, and 20-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by EP 0215536 A2, Costar Corporation (Costar).
Regarding claim 1 and 15, Costar teaches a dispensing system (system of Fig 1, abstract: 'The hand tool for transferring media from a source to a multi-well dish ') comprising:
a container including multiple channels, each channel capable of containing an amount of a liquid (container defined by members 25, 27, T, with channels extending through member T, each channel capable of containing fluid, Para [0014]: • The transfer plate T shown in FIGS. 8 to 11 includes a base 62, membrane 64 and cover 66', channels 68, Fig 8 can hold fluid);
a well plate including multiple wells, each well being configured to align with a respective channel of the container (well plate C, Fig 1, Para [0012]:' In FIGS. 1 and 2, a 96-well culture dish C is suggested supported on a surface Son which base 20 also rests.', a well plate with multiple channels aligned with the channels of the container);
a plunger including multiple protrusions, each protrusion being configured to be inserted into a respective channel of the container (plunger 34 with protrusions 100, Fig 1 ), and movement of the plunger toward the container forces each protrusion to be inserted into the respective channel of the container thereby driving liquid from the respective channel and into the aligned well of the well plate (Fig 17, Para [0019]: 'To discharge the column of liquid 102a into the well 104a, the piston 100 is rapidly driven to a lowermost position in chamber 68 as shown in FIG. 17.').
Regarding claim 2, Costar teaches the dispensing system of claim 1, wherein the multiple channels include at least one of at least 24 channels, at least 48 channels, or at least 96 channels (Para [0014]: 'The transfer plate T ... includes an array of funnel-shaped chambers 68 arranged in eight parallel rows of twelve chambers each', 96 channels are taught),
wherein the multiple wells include at least one of at least 24 wells, at least 48 wells, or at least 96 wells (Para [0011]: 'a multi-well dish which typically may be a 96-well tissue culture plate', 96 wells are taught), and
wherein the multiple protrusions include at least one of at least 24 protrusions, at least 48 protrusions, or at least 96 protrusions (100, Figs 1, 17, a protrusion for each well is taught, thereby providing 96 protrusions).
Regarding claim 3, Costar teaches the dispensing system of claim 1, wherein the multiple channels include an array of channels (68, Fig 8, the multiple channels are shown being arranged in an array, Para [0014]),
wherein the multiple wells include an array of multiple wells (Fig 8, the channels are taught being formed in an array and the wells are shown being provided aligned with each channel, Para [0024]: • The ports 33 are disposed beneath the rails 32 so as to enable the user to visually confirm that the funnel-shaped stems 76 are precisely aligned with the wells in the dish C'), and
wherein the multiple protrusions include an array of multiple protrusions (Fig 1, the protrusions are taught corresponding to the channels which are shown to be provided in an array I Fig 8).
Regarding claim 5-7, Costar teaches the dispensing system of claim 1, wherein the container includes a chamber (chamber formed inside opening 31, Fig 7), and
wherein the well plate is configured to be inserted into the chamber to align the well plate relative to the container thereby aligning each well of the well plate with the respective channel of the container (Fig 1, the well plate C is taught being inserted into the chamber through the bottom of the device aligning the wells with the channels, Para [0022]: 'The plan dimensions of the base 20 are such that it will just fit over the dish C or reservoir R.').
The wells and channels are aligned and the channels retain liquid.
Regarding claim 8, Costar teaches the dispensing system of claim 1, wherein each channel is loaded with a respective amount of liquid (Para [0019]: 'The partially filled chamber 68 is then removed from the liquid 102 in the well 104, and the chamber 68 retains the column of fluid 102a because of the difference in pressure above and below the column'), and further comprising a barrier coupled to an upper surface of the container, the barrier extending across a first opening of a channel of the container to retain the liquid within the channel (64, Fig 8, Para [0033]: 'The piston 100 in FIG. 16 is shown in its lowermost position wherein it fully extends the diaphragm 64 to empty the transfer plate. With the contents of the transfer plate discharged, the operator may return the lever 23 to the position shown in FIG. 2 (or FIG. 1) and the sequence of steps described may be repeated by again drawing media from the reservoir R into the transfer plate and thereafter discharging the media from the transfer plate into the next 96-well dish.', barrier 64 seals the top of the channels and uses pressure to retain fluid).
Regarding claim 21, Costar teaches a method for dispensing a fluid (system of Fig 1, taught dispensing fluid, abstract: 'The hand tool for transferring media from a source to a multi-well dish'), the method comprising:
aligning a first protrusion of a plunger with a first channel of a container containing a first liquid (protrusions 100 of plunger 34, Fig 1, aligned with channels 68 of container T, Figs 16-17, shown containing a liquid 102a, Fig 16);
aligning a second protrusion of the plunger with a second channel of the container containing a second liquid (Fig 1, multiple protrusions are taught for each channel, Fig 8, multiple channels are taught each holding a liquid as shown in Fig 17);
aligning a first well of a well plate with the first channel of the container (Para [0024]:' ... so as to enable the user to visually confirm that the funnel-shaped stems 76 are precisely aligned with the wells in the dish C', well plate C, Fig 1, also seen in Fig 18);
aligning a second well of the well plate with the second channel of the container (para [0024], Fig 1, the well plate is taught being placed such that the channels and protrusions are aligned); advancing the first protrusion into the first channel of the container to dispense the first liquid from the channel into the first well of the well plate (Fig 16-17, each protrusion is taught being advanced into its respective channel to dispense liquid); and
advancing the second protrusion into the second channel of the container to dispense the second liquid from the second channel into the second well of the well plate (Fig 16-17, each protrusion is taught being advanced into its respective channel to dispense liquid).
Claim Rejections - 35 USC § 103
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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Costar, EP 0215536 A2 as applied above.
Costar does not specify that each channel of the multiple channels contains a different amount of the liquid.
The Applicant is advised that the Supreme Court recently clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143).
Common sense, predictability, knowledge, and skill of one of ordinary skill in the art may suffice to establish obviousness.
It would have been obvious to and within the common sense, knowledge, and skill of one ordinary skill in the art before the effective filing date of the invention to choose to have different amounts of liquid in each of the wells to transfer different amounts of liquid to the wells as such would yield results predicable to one of ordinary skill in the art.
Claim(s) 13-14, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Costar, EP 0215536 A2 as applied above, and further in view of Godin et al, US 20040141885 A1.
Costar does not disclose a spring coupled between the container and the plunger, the spring configured to bias the plunger to move towards the container; and a lock configured to, with the spring biased, block relative movement between the plunger and the container and a second plunger including a third protrusion.
Godin discloses a dispensing system comprising a plunger 50 comprising protrusions 70 each inserted in containers 120 (Figure 1A). See also Figure 8 and corresponding description.
A spring (not shown) is used to bias the piston's position to one end of its travel. This biasing spring can be located in various places, such as between the mounting plate 244 and the top of the pipette barrel 270 (container). (paragraph 0075) Furthermore, the travel of the piston (plunger) is limited/blocked by a spacer (lock) 390.
It would have been obvious to and within the common sense, knowledge, and skill of one ordinary skill in the art before the effective filing date of the invention to modify the device of Costar to include a spring and a spacer structure to control the relative movement of the plunger as taught by Godin as such would yield results predicable to one of ordinary skill in the art.
As to claim 22, discloses the claimed invention except for the use of a second plunger comprising a third protrusion . It would have been obvious to and within the common sense, knowledge, and skill of one ordinary skill in the art before the effective filing date of the invention to include a second plunger including a third protrusion to provide a liquid from a third container, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art.
Allowable Subject Matter
Claims 9-12 and 16-19 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Godin does not teach nor fairly suggests the barrier is a first barrier, and further comprising a second barrier coupled to a lower surface of the container, the second barrier extending across a second opening of each channel of the multiple channels of the container to retain the liquid within each of the multiple channels; the channel is a first channel, the liquid is a first liquid, the well is a first well, the plunger is a first plunger that includes a hole, the protrusion is a first protrusion, and further comprising: a second plunger having a second protrusion, wherein the container includes a second channel and a wall that separates the first channel from the second channel, the second channel containing a second liquid, and the second channel being configured to align with the hole of the first plunger and the well of the well plate, wherein movement of the second plunger toward the container advances the second protrusion through the hole of the first plunger and into the second channel of the container thereby driving the second liquid from the second channel into the well of the well plate; and the channel is a first channel, the liquid is a first liquid, the well is a first well, the plunger is a first plunger that includes a second channel containing a second liquid, the protrusion is a first protrusion, and further comprising: a second plunger having a second protrusion, wherein movement of the second plunger toward the container advances the second protrusion through the hole of the first plunger and into the second channel of the first plunger thereby driving the second liquid from the second channel into the well of the well plate.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. SANDERSON COLIN JOHN; COTE; Richard; Danehy; Ronald et al.; Mettier; Ivo et al.; Muraishi; Katsuaki et al.; Jackson, Joseph H. III et al.; Massaro; Peter et al.; LEE; TE-CHENG; Luedemann; Hans-Christian; Panzer; Armin et al.; Warhurst; Julian et al.; Powers, Elaine; Cote; Richard; BORK; Olaf; Ingenhoven, Nikolaus et al.; Tajima; Hideji; Yiu; Felix H.; IZUME; Yohei et al.; SUNG; Chen-An et al.; Steinbrenner; Bernd et al.; Schwartz, H. Donald; Lehtinen; Kauko et al.; Von Beichmann; Boris et al.; Tubbs; Kemmons A. et al.; Park; Han Oh et al.; Campbell; Adrian M. et al.; Lehtinen, Kauko et al.; Sullivan; James T.; Naumann; Uwe et al.; NAUMANN; Uwe; Wilmer; Jens; Bevirt; JoeBen et al.; Massaro; Peter; Maiefski; Romaine et al.; Tuunanen; Jukka; Minshew, Jr.; Edward C. et al.; Yiu; Felix H.; Marcelli; Aline; Hunicke-Smith; Scott P. et al.; Carl; Richard A.; Fernwood; George G. et al.; Root; David et al.; Karg; Jeffrey A. et al.; Sekine; Teruaki; Suovaniemi; Osmo A. et al.; Maeda; Yoshio; Meltzer; Walter C. et al.; Suovaniemi; Osmo et al.; Kane; Jeffrey; Bennett, Jr.; John T. et al.; Bennett; John T. et al.; Leaback; David H.; Haxo, Jr.; Francis Theodore et al.; Tuunanen; Jukka et al.; Schoeneck; Richard J. et al.; Yiu; Felxi; Bienert; Klaus et al.; Tajima; Hideji; Flesher; Robert W.; and Salomaa; Kari et al. disclose dispensing systems and methods of use.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
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/BRIAN R GORDON/ Primary Examiner, Art Unit 1798